BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD BEARING

    MDR report key: 22735370 · Received August 7, 2025

    Report

    Report Number
    3002806535-2025-00333
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    December 28, 2024
    Report Date
    September 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G2, G3, G6, H2, H6, H10, H11. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED, AND NO PICTURES WERE PROVIDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. DUE TO INSUFFICIENT PRODUCT INFORMATION, THE COMPATIBILITY OF THE INVOLVED PRODUCTS COULD NOT BE VERIFIED. A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED DUE TO MISSING REFERENCE AND LOT NUMBERS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. DURING THE INVESTIGATION PROCESS, A REVIEW OF THE STERILE CERTIFICATIONS WAS NOT REVIEWED, AS NO PRODUCT PART/LOT INFORMATION WAS PROVIDED. HOWEVER, ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (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. G2: CHINA. JOURNAL ARTICLE CITATION: HAO, Y., LI, J., LI, J. ET AL. COMPARISON OF CLINICAL OUTCOMES OF BILATERAL AND UNILATERAL UNICOMPARTMENTAL KNEE ARTHROPLASTY FOR THE TREATMENT OF KNEE OSTEOARTHRITIS. SCI REP 14, 30953 (2024). HTTPS://DOI.ORG/10.1038/S41598-024-81995-7. 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.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS RETRIEVED FROM SCIENTIFIC REPORTS (2024) THAT REPORTED A STUDY FROM CHINA. THE PURPOSE OF THE STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF SIMULTANEOUS BILATERAL AND UNILATERAL UKA. A RETROSPECTIVE REVIEW WAS PERFORMED BETWEEN 2019 AND 2022 ON 280 PATIENTS (130 SIMULTANEOUS BILATERAL VS. 150 UNILATERAL OXFORD UKA) WHO PERFORMED BY TWO EXPERIENCED SURGEONS. PATIENTS IN BOTH GROUPS UNDERWENT SURGERY ACCORDING TO THE MICROPLASTY INSTRUMENTATION SYSTEM, WITH CONGRUENT POSTOPERATIVE MANAGEMENT AND CAREFULLY STANDARDIZED FOLLOW-UP. THE INDICATION FOR SURGERY WAS U-UKA GROUP EXHIBITED UNILATERAL KNEE OSTEOARTHRITIS, WHILE THE SB-UKA GROUP HAD BILATERAL MANIFESTATIONS. THE U-UKA GROUP CONSISTED OF 34 MEN AND 116 WOMEN, WITH A MEAN AGE OF 63 (50¿81) YEARS AND A BMI OF 27.3 (20.2¿39.6) KG/M2. ON THE OTHER HAND, THE SB-UKA GROUP CONSISTED OF 4 MEN AND 106 WOMEN, WITH A MEAN AGE OF 62.6 (49¿80) YEARS AND A BMI OF 27.7 (19.5¿39.8) KG/M2. FOLLOW-UP WAS CONDUCTED AT ONE, THREE, SIX-, AND TWELVE-MONTHS POST-SURGERY IN BOTH GROUPS. THE STUDY REPORTED ONE PATIENT WITHIN THE SB-UKA GROUP, LEFT KNEE PROSTHETIC JOINT INFECTION RESULTING IN STAGE 1 REVISION. 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
    531526 UNKNOWN OXFORD BEARING KNEE PROTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11 NARRATIVE.