BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 12X63/67

    MDR report key: 17454329 · Received August 3, 2023

    Report

    Report Number
    0001825034-2023-01820
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    July 10, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PHOTOGRAPH. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED EXPLANTED IMPLANTS THAT SHOW A LARGE AMOUNT OF WEAR. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS ANTERIOR SUBLUXATION OF THE TIBIA IN RELATION TO THE FEMUR WITH METAL-ON-METAL CONTACT OF THE IMPLANTS CONSISTENT WITH POSTERIOR LINER WEAR OR LINER DISPLACEMENT. THERE IS NO FRACTURE OR EVIDENCE OF IMPLANT LOOSENING. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D6A IMPLANT DATE: UNKNOWN DATE IN (B)(6) 2011. D10 MEDICAL DEVICES: VANGRD CR POR/HA FEM - RT 62.5 CATALOG#: 167026 LOT#: 2013063. BMET REGENX PRI TIB TRAY 67MM CATALOG#: 141272 LOT#: 507270. BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 695600. G2 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01820 AND 0001825034-2023-02040. D10 MEDICAL DEVICES: VANGRD CR POR/HA FEM - RT 62.5, CATALOG#: 167026 LOT#: 2013063. BMET REGENX PRI TIB TRAY 67MM, CATALOG#: 141272 LOT#: 507270. BIOMET FINNED PRI STEM 40MM, CATALOG#: 141314 LOT#: 695600. UNKNOWN PATELLA, CATALOG#: NI LOT#: NI.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT AND PATELLA WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507594 VNGD CR TIB BRG 12X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 833940

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.| SEE H10.