UNKNOWN DEPUY DOME PATELLA WITH CENTRAL PEG 38MM
Received Dec 16, 2011
Report 1818910-2011-26322 · MDR key 2379809
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fall
Narrative
Description of Event or Problem
LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2011, THE PATIENT SUFFERED A FALL AND SUBSEQUENT INJURY. IT IS FURTHER ALLEGED THE PROSTHESIS IMPLANTED IN THE PATIENTS LEG WAS MIS-ALIGNED WHICH CREATED A FAILURE OF THE QUADRICEPS MECHANISM DURING AN UPHILL GATE. IT IS ALSO ALLEGED THE MAL-ALIGNMENT RESULTED IN A FRACTURE OF THE INFERIOR POLE OF THE PATELLA.
Additional Manufacturer Narrative
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Remedial action
- Other