BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN OXFORD BEARING

    MDR report key: 23189381 · Received October 1, 2025

    Report

    Report Number
    3002806535-2025-00475
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 27, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) B3: THE PUBLICATION DATE OF THE ARTICLE WAS USED AS THE EVENT DATE. D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS BOTH THE ITEM AND LOT NUMBERS OF THE DEVICE ARE UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D10 - ASSOCIATED MEDICAL DEVICES: UNKNOWN OXFORD TIBIAL COMPONENT; ITEM# UNKNOWN; LOT# UNKNOWN. UNKNOWN OXFORD FEMORAL COMPONENT; ITEM# UNKNOWN; LOT# UNKNOWN. G2 - FOREIGN: GERMANY 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. 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. JOURNAL ARTICLE CITATION: HARIRI, M., FREYTAG, J., KOCH, KA. ET AL. REVISION SURGERY AFTER FAILURE OF LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT WITH A MOBILE-BEARING DEVICE: A RETROSPECTIVE NON -DESIGNER CASE-SERIES. ARCH ORTHOP TRAUMA SURG 145, 204 (2025). HTTPS://DOI.ORG/10.1007/S00402-025-05822-Y.

    Description of Event or Problem · 0

    ON 08-SEP-2025, A JOURNAL ARTICLE WAS RETRIEVED FROM THE ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2025) THAT REPORTED A RETROSPECTIVE STUDY FROM GERMANY. THE PURPOSE OF THE STUDY WAS TO REPORT ON THE FAILURE MODES IN LATERAL MOBILE BEARING-UNICOMPARTMENTAL KNEE REPLACEMENT, AS WELL AS THE RESULTS OF DIFFERENT REVISION STRATEGIES. THE STUDY REVIEWED THIRTEEN PATIENTS WHO EXPERIENCED A FAILURE AND REQUIRED REVISION SURGERY AT THE UNIVERSITY OF HEIDELBERG BETWEEN 2008 AND 2020. IN ALL INDEX SURGERIES WERE INDICATED FOR PRIMARILY OSTEOARTHRITIS AND USED AN OXFORD DOMED LATERAL PROSTHESIS (ZIMMER BIOMET INC., WARSAW, INDIANA, USA). DEPENDING ON THE BONE QUALITY, THE USE OF A CEMENTED OR UNCEMENTED FIXATION OF THE FEMORAL COMPONENT WAS CHOSEN, WHEREAS THE TIBIAL COMPONENT WAS ALWAYS CEMENTED IN BOTH GROUPS. THE STUDY POPULATION HAD A MEAN AGE OF 32.2 YEARS AT TIME OF INDEX SURGERY AND A MEAN AGE OF 67.2 YEARS AT THE TIME OF THE REVISION SURGERY; (4 MALES/9 FEMALES). FOLLOW-UP WAS CONDUCTED WITH A MEAN LENGTH OF 94.7 ± 36.4 MONTHS. THE STUDY REPORTED THAT SIX CASES EXPERIENCED AN ATRAUMATIC BEARING DISLOCATION AND UNDERWENT A BEARING EXCHANGE. SUBSEQUENTLY, DISLOCATED AGAIN AND FOUR CASES UNDERWENT A CONVERSION TO A TOTAL KNEE ARTHROPLASTY AND THE REMAINING TWO CASES UNDERWENT A REVISION TO A FIXED BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674187 UNKNOWN OXFORD BEARING KNEE PROSTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.