BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 71MM

    MDR report key: 12281018 · Received August 5, 2021

    Report

    Report Number
    0001825034-2021-02306
    Event Type
    Injury
    Date Received
    August 5, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL REVIEW INDICATES THAT PATIENT STATES RIGHT KNEE IS EXPERIENCING ISSUES, AND LEFT KNEE HAS NO ISSUES. STATES WALKS DIFFERENTLY NOW KNEE GOES INWARD AND LOWER LEG GOES OUTWARD. X-RAY REVIEW INDICATES THAT RIGHT KNEE ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO FRACTURE OR EVIDENCE OF IMPLANT LOOSENING. THERE IS MILD ASYMMETRIC RIGHT KNEE VALGUS WHEN COMPARED TO THE LEFT KNEE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 62.5 CATALOG # 183006 LOT # J6555744. VNGD CR LIP TIB BRG 16X71/75MM CATALOG # 183546 LOT # 324420. SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # 613630. BIOMET FINNED PRI STEM 40MM CATALOG # 141314 LOT # 978350. STRYKER CEMENT CATALOG # UNKNOWN LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2021-02314 0001825034-2021-02315 0001825034-2021-02316 0001825034-2021-02317. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PAIN AND A CROOKED KNEE POST SURGERY. ADDITIONALLY, THE PATIENT WAS WALKING DIFFERENTLY. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179177 BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS KNEE OIY ZIMMER BIOMET, INC. N/A 686560

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10 NARRATIVE