BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX SERIES A PATELLA

    MDR report key: 7043185 · Received November 17, 2017

    Report

    Report Number
    0001825034-2017-10387
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD FEMUR # 183068, LOT # 170170. BIOMET FINNED PRIMARY STEM # 141314, LOT # 793550. VANGUARDS CR TIBIAL BEARING # 183442, LOT # 396050. SIG TKA GDE/MDL SET # 42-422551, LOT # 141618. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMS THE REPORTED EVENT AS THE PEGS ARE BROKEN OFF. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO A LABELING DEFICIENCY. 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 · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE DUE TO PAIN AND FRACTURE OF THE PATELLA PEGS. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE IMPLANT FRACTURING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820257 REGENEREX SERIES A PATELLA PROSTHESIS KNEE MBH ZIMMER BIOMET, INC. N/A 870310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R