ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING
Report
- Report Number
- 0001825034-2018-08270
- Event Type
- Injury
- Date Received
- August 20, 2018
- Report Date
- July 3, 2019
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDI
- PMA / PMN Number
- PK002757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND RADIOGRAPHIC INSPECTION, HOWEVER, THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. ALTHOUGH IT IS REPORTED THAT THE PATIENT HAD FALLEN ON MULTIPLE OCCASIONS AND REFUSED TO WEAR A KNEE BRACE FOR STABILITY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL DEVICES ¿ ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS, CATALOG #: 150477, LOT #: 250110; ORTHOPEDIC SALVAGE SYSTEM POROUS COATED STRAIGHT IM STEM 16.5MM X 150MM, CATALOG #: 150451, LOT #: 785670; BIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM, CATALOG #: 11-150863, LOT #: 156460; ORTHOPEDIC SALVAGE SYSTEM RESURFACING POROUS COATED FEMORAL COMPONENT 5CM RIGHT, CATALOG #: 150352, LOT #: 121720; ORTHOPEDIC SALVAGE SYSTEM YOKE, CATALOG #: 150493, LOT #: 122870; ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CATALOG #: 150478, LOT #: 233570; ORTHOPEDIC SALVAGE SYSTEM 71MM MODULAR TIBIAL BASE WITH PLUG; CATALOG #: 150422, LOT #: 140340; ORTHOPEDIC SALVAGE SYSTEM POROUS COATED IM STEM WITH SCREW 14.5MM X 90MM, ORTHOPEDIC SALVAGE SYSTEM 22MM TIBIAL BEARING; CATALOG #: 150415, LOT #: 982670; ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 407180; VANGUARD SERIES A STANDARD PATELLA 37MM X 10MM, CATALOG #: 184768, LOT #: 533400. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES CURRENTLY REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT. 0001825034-2018-08263, 0001825034-2018-08264, 0001825034-2018-08265, 0001825034-2018-08266, 0001825034-2018-08267, 0001825034-2018-08268, 0001825034-2018-08269, 0001825034-2018-08270, 0001825034-2018-08271, 0001825034-2018-08272, 0001825034-2018-08273, 0001825034-2018-08274. DEVICE REMAINS IMPLANTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION.
IT IS REPORTED THAT THE PATIENT IS EXPERIENCING POST-OPERATIVE PAIN, NEUROPATHY, SEVERAL REPORTS OF FALLING AND ISSUES WITH RANGE OF MOTION APPROXIMATELY THREE (3) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
IT IS REPORTED THAT THE PATIENT IS EXPERIENCING POST-OPERATIVE PAIN, NEUROPATHY, SEVERAL REPORTS OF FALLING AND ISSUES WITH RANGE OF MOTION APPROXIMATELY THREE (3) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT HAS ENROLLED IN ADDITIONAL PHYSICAL THERAPY TO ADDRESS THESE COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639072 | ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING | PROSTHESIS, KNEE | JDI | ZIMMER BIOMET, INC. | N/A | 180710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |