DePuy Synthes CMF Recall Lawsuits
A nationwide recall for DePuy Synthes craniomaxillofacial (CMF) distraction systems has been issued, due to the risk of problems that may cause the jaw implant devices to reverse direction, potentially leading to severe and life-threatening injury.
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing the potential for DePuy Synthes CMF lawsuits on behalf of infants or adults who have experienced problems with the jaw lengthening system, which is typically used to guide and stabilize jaw bone growth following a birth defect or traumatic jaw injury.
If the DePuy Synthes CMF reverses direction, it may cause users to suffer:
- Tracheal Obstruction
- Surgical Intervention to Replace the jaw
- Respiratory Arrest
- Wrongful Death
CONTACT OUR LAWYERS ABOUT THE DEPUY SYNTHES CMF RECALL
DePuy Synthes Craniomaxillofacial (CMF) Problems
The DePuy Synthes CMF is designed to gradually lengthen or distract the jaw bone (mandibular body) or lower side of the jaw (ramus), guiding bone growth over time. It has been used in both adult and pediatric, where it may pose a particularly serious risk of severe injury or death.
In many cases for children with birth defects, physicians will use an osteotome to crack or divide the jaw bone at an area of deformity, locking the mesh plates in place to allow for normal bone distraction.
For older children and adult patients, the devices may be used for traumatic injuries, such as broken jaws from accidents. The CMF distractor allows the jaw bone to gradually lengthen.
The DePuy Synthes CMF recall was issued by the FDA on August 28, following at least 15 reports of injury where the devices revered direction. This not only causes the loss of the desired distraction direction after surgery, but could also lead to serious or life-threatening complications.
The most at-risk patients are infants and very young children, because sudden failure of the device may cause obstruction of the trachea, potentially leading to respiratory arrest or death.
Older children or adults who undergo the CMF implant may be able to maintain an open airway in the event of device failure, posing a serious risk, but probably one that is not life-threatening. Although older patients may not suffer from tracheal obstruction, failure of the device may still result in the need for surgical intervention to replace the failed device. Patients may also have to undergo prolonged distraction therapy in the event the DePuy Synthes CMF fails.
Depuy Synthes has sent an “Urgent Notice” to all customers to inform them of the affected products and issues in April 2014. Instructions provided to hospitals and medical providers asked all customers to review their inventory and remove all affected lots from stock.
Patients with distractors currently implanted should be closely monitored until a clinical or imaging examination confirms the appropriate course of action. Physicians have been asked to schedule appointments to see patients with CMF distractors currently implanted to immediately determine the severity of the abnormality, the age of the patient, the patient’s caregiving environment, ability to protect their airway, and ability to maintain nutritional status to determine the best type of post-operative care and supportive treatment.
DePuy Synthes Craniomaxillofacial (CMF) Lawyers
As a result of defects with the device, financial compensation may be available for individuals who suffered a severe injury or problems with a recalled DePuy Synthes Craniomaxillofacial (CMF) Distractor.
The recall lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for infants and adults throughout the United States who may have experienced complications after a DePuy Synthes CMF distractor reversed direction.
All cases are reviewed by our law firm under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire a lawyer and we receive no attorney fees or reimbursement of expenses unless we are successful obtaining a recovery.
To review whether you, your child or a loved one may have a case, request a free consultation and claim evaluation.
No Comments • Add Your Comments