BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 34 3 PEG

    MDR report key: 8043852 · Received November 6, 2018

    Report

    Report Number
    0001825034-2018-10351
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    September 24, 2018
    Report Date
    July 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION APPROXIMATELY FIVE MONTHS POST IMPLANTATION DUE TO STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VGXP XP INLK PRI TIB TRAY; P/N: 195758, L/N: 999400; BCM-PALACOS-UNK; P/N: UNK, L/N: UNK; VGXP INTLK FEMORAL; P/N: 195926, L/N: 162120; SERIES A PAT STD 34; P/N: 184766, L/N: 346140; VGXP XP E1 TIB BRG LM; P/N: 195892, L/N: 257460; VGXP XP E1 TIB BRG LL; P/N: 195822, L/N: 168570. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09943, 0001825034 - 2018 - 09944, 0001825034 - 2018 - 10351, 0001825034 - 2018 - 09948, 0001825034 - 2018 - 09949.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY 5 MONTHS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION DUE TO STIFFNESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883661 SERIES A PAT STD 34 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 346140

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R