VANGUARD CR ILOK FEM-LT 60 60
Report
- Report Number
- 0001825034-2022-01120
- Event Type
- Injury
- Date Received
- May 5, 2022
- Date of Event
- May 17, 2022
- Report Date
- September 12, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K113550
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BMET ARCOM AP PAT W/WIRE 31MM IRE 31MM: CATALOG#11-150826, LOT#453550; BIOMET ILOK PRI TIB TRAY 63MM: CATALOG#141211, LOT#480960; BIOMET FINNED PRI STEM 40MM: CATALOG#141314, LOT#843360; VNGD CR TIB BRG 12X63/67 MM: CATALOG#183422, LOT#839540. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01121; 0001825034-2022-01122; 0001825034-2022-01123; 0001825034-2022-01124. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B2; B3; B4; B5; D6; G3; H2; H6; H10. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - FEMUR. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS PROVIDED STATE THAT THE PATIENT WAS EXPERIENCING PAIN, INSTABILITY. X-RAY REVIEW BY THIRD PARTY STATES THAT THE X-RAYS DEMONSTRATE BILATERAL TOTAL KNEE ARTHROPLASTY WITHOUT RADIOLUCENCY TO SUGGEST LOOSENING. NO FRACTURE OR NO SIGNIFICANT JOINT EFFUSION WAS SEEN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT STATES TO HAVE PERSISTENT PAIN FOR THE PAST EIGHT YEARS AND SEVEN MONTHS POST IMPLANTATION. THE PATIENT ALSO EXPERIENCES SWELLING IN THE KNEE WITH WEATHER CHANGES AND STATES THAT THE LEFT LEG HAS BEEN LONGER THAN THE RIGHT SINCE THE SURGERY. INSTABILITY WAS NOTED UPON ASSESSMENT AND THE PATIENT UNDERWENT BONE SCANS AND LAB WORK TO DETERMINE ELIGIBILITY FOR REVISION. FINAL OUTCOME IS PENDING AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED PERSISTENT PAIN, SWELLING IN THE KNEE WITH WEATHER CHANGES, AND STATES THAT THE LEFT LEG HAS BEEN LONGER THAN THE RIGHT SINCE IMPLANTATION. INSTABILITY WAS NOTED UPON ASSESSMENT AND THE PATIENT UNDERWENT BONE SCANS AND LAB WORK TO DETERMINE ELIGIBILITY FOR REVISION. APPROXIMATELY NINE YEARS AND NINE MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN, SWELLING, AND LOOSENING. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1464005 | VANGUARD CR ILOK FEM-LT 60 60 | PROSTHESIS, KNEE | JWH | ZIMMER BIOMET, INC. | 247590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H| O |