UNKNOWN OXFORD BEARING
Report
- Report Number
- 3002806535-2025-00408
- Event Type
- Injury
- Date Received
- August 22, 2025
- Date of Event
- September 1, 2024
- Report Date
- April 15, 2026
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. BASED ON THE JOURNAL ARTICLE, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.¿
(B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN OXFORD TIBIAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. UNKNOWN OXFORD FEMORAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. JOURNAL ARTICLE CITATION: FRICKA, K. B., WILSON, E. J., STRAIT, A. V., HO, H., HOPPER, JR, R. H., HAMILTON, W. G., & SERSHON, R. A., ET AL (2024). OUTCOMES OF FIXED VERSUS MOBILE-BEARING MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE BONE & JOINT JOURNAL, 106-B NO.9, 916-923. HTTPS://DOI.ORG/10.1302/0301-620X.106B9.BJJ-2024-0075.R1. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
A JOURNAL ARTICLE WAS RETRIEVED FROM THEN BONE & JOINT JOURNAL (2024 THAT REPORTED A STUDY FROM ALEXANDRIA, VIRGINIA, USA. THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES OF FIXED-BEARING (FB) AND MOBILE-BEARING (MB) UKAS FROM A SINGLE HIGH-VOLUME INSTITUTION. THE STUDY REVIEWED PRIMARY CEMENTED MEDIAL UKAS PERFORMED BY SEVEN SURGEONS FROM JANUARY 2006 TO DECEMBER 2022. A TOTAL OF 2,999 UKAS WERE IDENTIFIED, INCLUDING 2,315 FB AND 684 MB CASES. THE 684 CASES IN THE MB GROUP USED THE PHASE 3 OXFORD PARTIAL KNEE WITH TWO FEMORAL PEGS. THE STUDY POPULATION HAD A MEAN AGE AT SURGERY WAS 66.0 (32.9 TO 92.1), YEARS AT TIME OF SURGERY; (NUMBER OF 300 MALES/384 FEMALES). MEAN LENGTH OF FOLLOW-UP 4.2 YEARS (3.6; 0.0 TO 15.6). THE STUDY REPORTED 10 PATIENTS WITHIN THE MB GROUP WITH BEARING DISLOCATION ALL REQUIRING COMPONENT REVISION SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262171 | UNKNOWN OXFORD BEARING | KNEE PROTHESIS | NRA | BIOMET UK LTD. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H11 NARRATIVE. |