BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS+ TIB BRG 14X71/75MM

    MDR report key: 7764066 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-04974
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 18, 2011
    Report Date
    August 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS- BIOMET CC I-BEAM TRAY 75MM CATALOG # 141224 LOT # J100916059, VNGD PS+ TIB BRG 14X71/75MM CATALOG # 183744 LOT # 742340, VAN PS OPEN INTL FEM-LT 62.5 CATALOG # 183126 LOT # 300590, VANGUARD FEM PEGS SET, CATALOG # 183099, LOT # 499700. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. X-RAYS SHOW FRACTURE OF THE PATELLA. ONCE FRAGMENT MAINTAINS THE PATELLAR TENDON AND THE OTHER FRAGMENT IS FREE OF PATELLAR TENDON. REVIEW OF THE PRIMARY SURGERY NOTES DID NOT INDICATE ANY INTRAOPERATIVE COMPLICATIONS. REVIEW OF THE REVISION OPERATIVE NOTES STATE THAT THERE IS PATIENT WAS TREATED WITH ORIF LEFT PATELLA WITH PATELLAR TENDON REPAIR, TIBIAL POLY EXCHANGE, TENDINOACHILLES ALLOGRAFT FOR PATELLAR TENDON RECONSTRUCTION. THERE WAS DISRUPTION OF THE ENTIRE EXTENSOR MECHANISM AND THERE IS FRAGMENTATION OF THE PATELLA. THERE IS A MAJOR FRAGMENT ASSOCIATED WITH THE PATELLAR TENDON AND A MAJOR FRAGMENT ASSOCIATED WITH THE PATELLAR BUTTON. THIS WAS NOT A FRANK PATELLAR TENDON RUPTURE, BUT A FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT WAS REPORTED THAT PATIENT WAS OSTEOPENIC. HOWEVER, ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO PATELLAR FRACTURE. THE POLYETHYLENE BEARING WAS EXCHANGED ALONG WITH AN OPEN REDUCTION INTERNAL FIXATION OF FRACTURED PATELLA, AND EXTENSOR MECHANISM RECONSTRUCTION WITH ACHILLES TENDON ALLOGRAFT WITH BONE BLOCK.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET CC I-BEAM TRAY 75 MM CATALOG # 141224 LOT # UNKNOWN. VNGD PS+ TIB BRG 14X71/75 MM CATALOG # 183744 LOT # UNKNOWN. VAN PS OPEN INTL FEM-LT 62.5 CATALOG # 183126 LOT # UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND/OR LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO RUPTURE OF PATELLAR TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603586 VNGD PS+ TIB BRG 14X71/75MM KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 742340

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R