UNKNOWN 10 PS PLUS ARTICULAR SURFACE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION DUE TO SIZE OF IMPLANT, PAIN, INSTABILITY, LIGAMENT LAXITY, IMPLANT WEAR, DISLOCATION, DIFFICULTY WALKING WITHOUT A CANE OR WALKER AND DIFFICULTY DOING ANY DAILY ACTIVITIES. DURING THE REVISION THE FEMORAL COMPONENT WAS NOTED TO BE OVERSIZED WITH SIGNIFICANT ANTERIOR AND POSTERIOR OVERHANG. THERE WAS ALSO SIGNIFICANT LIGAMENT LAXITY WITH FLEXION AND EXTENSION. ALTHOUGH MEDIAL WEAR WAS NOTED ON THE PATELLAR COMPONENT, THIS REMAINED IN PLACE WITH A RETINACULUM REPAIR PERFORMED TO IMPROVE TRACKING. ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-01702, 0001825034-2022-01704, 0001825034-2022-00713-2. MEDICAL PRODUCT UNKNOWN VANGUARD 65 FEMORAL, UNKNOWN 80MM STEM, UNKNOWN 83 TIBIAL TRAY. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PRIMARY OPERATIVE NOTES STATE THERE WERE NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES STATE THAT PATIENT WAS REVISED DUE TO PAIN AND LIGAMENT INSTABILITY. GROSS LAXITY IN EXTENSION AND FLEXION. PATELLA SHOWED MEDIAL WEAR CONSISTENT WITH SUBLUXATION OR DISLOCATION. PATELLAR BUTTON INTACT AND DECISION WAS MADE TO RETAIN, LATERAL RETINACULAR RELEASE PERFORMED TO IMPROVE PATELLAR TRACKING. NOTES ALSO STATE THAT IMPLANTS APPEAR OVERSIZED AND FEMORAL COMPONENT SHOWS SIGNIFICANT ANTERIOR AND POSTERIOR OVERHANG. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.