BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 37MM

    MDR report key: 7558940 · Received May 31, 2018

    Report

    Report Number
    0001825034-2018-03670
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 1, 2018
    Report Date
    February 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    Z-2068-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. PATIENT WAS EXPERIENCING PAIN AND X-RAYS SHOWED THE PATELLA HAD DISLODGED FROM THE PEGS. PATELLA WAS REMOVED AND SURGEON ALSO FOUND A RETAINED WOUND VAC SPONGE. EVIDENCE OF METALLOSIS IN THE SYNOVIUM. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE REMAINS UNCHANGED BY THE ADDITIONAL INFORMATION RECEIVED. 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). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNIQUE IDENTIFIER (UDI): (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET FINNED PRIMARY STEM, CATALOG #: 141314, LOT #: 868150, BIOMET REGENEREX PRIMARY TIBIAL TRAY, CATALOG #: 141273, LOT #: 999910, VANGUARD CR POROUS FEMORAL, CATALOG #: 183066, LOT #: 928240, EI VANGUARD PS TIBIAL BEARING, CATALOG #: EP-183642, LOT #: 191480. REPORTED EVENT WAS CONFIRMED BY REVIEW OF ACTUAL DEVICE RECEIVED. VISUAL INSPECTION OF THE RETURNED PATELLA CONFIRMS THAT PEGS HAVE SHEARED OFF THE DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS IDENTIFIED RELEVANT TO THE REPORTED EVENT. 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. 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 THE PATIENT HAD A REVISION PROCEDURE APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO PAIN, METALLOSIS IN THE SYNOVIUM, AND PATELLA FAILURE. DURING THE PROCEDURE, THE SURGEON IDENTIFIED AND REMOVED AN UNKNOWN RETAINED SPONGE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A PATELLA COMPONENT FAILURE AND POST FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401317 RGX 3 PEG SER A PATELLA 37MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 091080

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R