ORTHOPEDIC SALVAGE SYSTEM ARCOM LS TIBIAL BEARING 12MM
Report
- Report Number
- 0001825034-2022-01658
- Event Type
- Injury
- Date Received
- July 20, 2022
- Date of Event
- June 28, 2022
- Report Date
- March 28, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KRO
- UDI-DI
- 00880304467989
- PMA / PMN Number
- K052685
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT DEVICES: ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 362150, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM AXLE CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM POLY LOCK PIN CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM NON-MODULAR TIBIA CATALOG #: NI LOT #: NI. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2022-01657.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION HAS BEEN REOPENED AND IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 362150, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM AXLE CATALOG #: NI LOT #: 912140, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: 330320, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM POLY LOCK PIN CATALOG #: NI LOT #: 807210, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS CATALOG #: NI LOT #: 606420, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL COMPONENT 7CM CATALOG #: NI LOT #: 027770, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM NON-MODULAR TIBIA 63MM CATALOG #: NI LOT #: 377970, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TAPERED DIAPHYSEAL SEGMENT CATALOG #: NI LOT #: 495630, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM BOWED STEM 11MM X 150MM CATALOG #: NI LOT #: 993980.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EXAMINATION OF THE RETURNED BEARING FOUND SIGNS OF BEING IMPLANTED (NICKED/GOUGED AND WORN) AND HAS FRACTURED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. X-RAYS WERE PROVIDED HOWEVER DUE TO POOR QUALITY THEY WERE NOT SENT FOR FURTHER REVIEW. OTHER MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION COMPLETED ON 28 MARCH 2023: (COMPLAINT RE-OPENED FOR MEDICAL RECORD RECEIVED). MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT EXPERIENCED PAIN, HYPEREXTENSION WITH STABLE GAIT AND NO INSTABILITY. X-RAY FOUND STABLE FEMUR AND TIBIAL COMPONENTS WITH INTERVAL CHANGE OF A PORTION OF THE ROTATING PLATFORM/YOKE. REVISION WAS PERFORMED AND DURING THE PROCEDURE, THE POLY WAS FOUND TO BE WORN WITH FRACTURED YOKE. BOTH FEMUR AND TIBIAL WERE INTACT. NO COMPLICATION WAS NOTED. COMPLAINT WAS CONFIRMED. NO CHANGE IN ROOT CAUSE, REMAINS AS A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS IMPLANT BREAKAGE POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
IT WAS REPORTED INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED ONE YEAR, FOUR MONTHS LATER DUE TO PAIN, HYPEREXTENSION, AND RADIOGRAPHIC CHANGES OF THE ROTATING PLATFORM/YOKE. DURING THE REVISION NOTED WEAR TO POLY, FRACTURE TO YOKE AND IMPENDING FAILURE OF HINGE COMPONENTS. THE HINGE COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. THE TIBIA AND FEMUR COMPONENTS REMAINED IMPLANTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405091 | ORTHOPEDIC SALVAGE SYSTEM ARCOM LS TIBIAL BEARING 12MM | PROSTHESIS, KNEE | KRO | ZIMMER BIOMET, INC. | N/A | 486590 | 00880304467989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | Required Intervention| H |