BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 12209659 · Received July 22, 2021

    Report

    Report Number
    3002806535-2021-00319
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    November 18, 2019
    Report Date
    September 15, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438242
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. COMPLAINT SUMMARY: - NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. - DEVICE IS USED FOR TREATMENT. - MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND BONE SCAN SHOWS NORMAL FLOW, WITH INCREASED TRACER UPTAKE PREDOMINANTLY INVOLVING THE TIBIAL COMPONENT. PATIENT REPORTED PAIN AND DECREASED ROM. SUSPECTED MICROSCOPIC LOOSENING OF THE TIBIAL COMPONENT. REVISION PERFORMED DUE TO MECHANICAL LOOSENING. - A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 4 COMPLAINTS REPORTED WITH THE ITEM 159547,6 COMPLAINTS REPORTED WITH THE ITEM 161469 AND 2 COMPLAINTS REPORTED WITH THE ITEM 154722. - A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. - NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. - THIS COMPLAINT WAS CONFIRMED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00304-2 3002806535-2021-00320-1 IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT UNI-CONDYLAR KNEE REPLACEMENT. THE PATIENT BEGAN TO DEVELOP PAIN AND DECREASED RANGE OF MOTION AND DESPITE MORE CONSERVATIVE INTERVENTIONS AND WAS REVISED TO A TOTAL KNEE DUE TO MICROSCOPIC LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF ANAT BRG LT MD SIZE 3 PMA, CATALOG #: 159547, LOT #: 707780. MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C LM PMA, CATALOG #: 154722, LOT #: 348110. MEDICAL PRODUCT: SIG TKA GDE/MDL SET 04-05, CATALOG #:42-422561, LOT #:171816. MEDICAL PRODUCT: BIOMET BC R 1X40 US, CATALOG #: 110035368, LOT #: 842EAH0505. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00304-1, 3002806535-2021-00320. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT UNI-CONDYLAR KNEE REPLACEMENT ON (B)(6) 2017. THE PATIENT BEGAN TO DEVELOP PAIN AND DECREASED RANGE OF MOTION AND DESPITE MORE CONSERVATIVE INTERVENTIONS WAS REVISED ON (B)(6) 2019 TO A TOTAL KNEE DUE TO MICROSCOPIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111563 OXF TWIN-PEG CMNTD FEM MD PMA OXFORD PARTIAL KNEE SYSTEM NRA BIOMET UK LTD. N/A 196210 05019279438242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R