BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PSRP INTLK FMRL LT 65

    MDR report key: 7931328 · Received October 3, 2018

    Report

    Report Number
    3002806535-2018-01117
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    March 8, 2017
    Report Date
    February 27, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET CASE NUMBER (B)(4). CORRECTION: B4, G4, G7, H2, H10. . UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR WILL NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER. THIS EVENT WILL BE REPORTED BY MEDWATCH FACILITY WARSAW BIOMET -(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINED INITIAL AND FINAL REPORT. REPORT: 3002806535-2018-01117 WAS VOIDED UNDER 3002806535-2018-01117-1 AS A REVIEW OF THE COMPLAINT IDENTIFIED THE PRODUCT AS WARSAW DESIGN CONTROL. IT WAS DETERMINED AN MDR SHOULD BE FILED UNDER MEDWATCH FACILITY WARSAW BIOMET. HOWEVER, IT HAS SINCE BEEN ESTABLISHED THAT THE PRODUCTS ARE UK DESIGN CONTROL AFTER ALL. THIS EVENT IS NOW REPORTED BY MEDWATCH FACILITY UK. D11 - MEDICAL PRODUCT -VNGD PSRP DCM BRG 10X65MM , ITEM 110016724, LOT 3744905. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01116-2. D11 - THERAPY DATE - DEVICE REMAINS IMPLANTED. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN JAPAN. DEVICE REMAINS IMPLANTED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. 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. H3 OTHER TEXT : DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR WILL NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER. THIS EVENT WILL BE REPORTED BY MEDWATCH FACILITY WARSAW BIOMET -(B)(4).

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A LEFT KNEE ATHROPLASTY. THE PATIENT SUFFERED A POSTERIOR DISLOCATION OF THE LEFT KNEE. A REDUCTION WAS PERFORMED UNDER GENERAL ANESTHESIA ON THE SAME DAY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VNGD PSRP DCM BRG 10X65MM, ITEM 110016724 , LOT 3744905, THERAPY DATE - DEVICE REMAINS IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-0116.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY AND SUBSEQUENTLY SUFFERED A POSTERIOR DISLOCATION OF THE LEFT KNEE. A REDUCTION WAS PERFORMED UNDER GENERAL ANESTHESIA ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770711 VNGD PSRP INTLK FMRL LT 65 HIP PROTHESIS JWH BIOMET UK LTD. N/A 3796404

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R