BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGX 3 PEG SER A PATELLA 31MM

    MDR report key: 10976524 · Received December 9, 2020

    Report

    Report Number
    0001825034-2020-04292
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304554412
    PMA / PMN Number
    K083782
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. PRIMARY OPERATIVE NOTES DOES NOT SUGGEST ANY INTRA OPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES STATE THAT ONE OF THE PATELLA PEG WAS FRACTURED, 2ND ONE WAS HALF BROKEN AND THIRD ONE IS INTACT. THE ROOT CAUSE OF THE PATELLA PEG FRACTURE WAS DETERMINED TO BE A LABELING AND TRAINING DEFICIENCY AS THE SURGICAL TECHNIQUE ADDENDUM FOR INSTALLATION OF REGENEREX PATELLA FAILED TO INCLUDE GUIDANCE ON DEPTH LINE INDICATION ON THE PEG DRILL BIT. ACTIONS WERE INITIATED TO ADDRESS THE ISSUE OF RISK OF FRACTURE WAS NOT INCLUDED IN THE RMF. THE PRODUCT HAS SINCE BEEN RECALLED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATE: B4, D9, G3, G6, H2, H3, AND H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SIGNS OF BEING IMPLANTED WITH WEAR, DISCOLORATION, FOREIGN MATERIAL, AND ONE OF THE POSTS HAVE FRACTURED OFF. NO UPDATE TO ROOT CAUSE. 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

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: VNGD PS OPEN POR FMRL RT 67.5 CATALOG#: 184510 LOT#: 184500. E1 VNGD PS TIB BRG 71/75X12 CATALOG#: EP-183642 LOT#: 004570. BMET REGENX PRI TIB TRAY 71MM CATALOG#: 141273 LOT#: 848410. BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 943120. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION NEARLY FIVE YEARS POST-IMPLANTATION DUE TO PATELLA IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443131 RGX 3 PEG SER A PATELLA 31MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 328680 00880304554412

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R