BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX 3 PEG SERIES A PATELLA 31MM

    MDR report key: 11692385 · Received April 20, 2021

    Report

    Report Number
    0001825034-2021-01123
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304554412
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THE PATELLA PEGS HAD BROKEN AND CONTINUED TO HAVE PAIN. METALLOSIS BLACKENED TISSUE AND SYNOVIUM WAS NOTED. PATELLA WAS JUST LOOSE AND WAS HELD IN BY SCAR TISSUE ALL 3 PEGS HAD BROKEN OFF. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. THE COMPLAINT SAMPLE WAS RETURNED AND VISUAL EXAMINATION OF THE PRODUCT IDENTIFIED SIGNS OF BEING IMPLANTED SUCH AS WEAR, DISCOLORATION AND FOREIGN MATERIAL AND ALL THREE POSTS HAD FRACTURED OFF. THE ROOT CAUSE REMAINS UNCHANGED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED POROUS FEMORAL COMPONENT RIGHT 65MM, CATALOG #: 184508, LOT #: 110980; BIOMET REGENEREX PRIMARY TIBIAL TRAY 71MM, CATALOG #: 141273, LOT #: 288640; VANGUARD E1 POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM, CATALOG #: EP-183640, LOT #: 302330; BIOMET FINNED PRIMARY STEM 40MM, CATALOG #: 141314, LOT #: 623390. THE COMPLAINANT HAS NOT YET INDICATED WHETHER THE PRODUCT WILL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND PATELLAR IMPLANT FRACTURE APPROXIMATELY FOUR (4) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS RELATED TO THE IMPLANTS. REVISION OPERATIVE NOTES NOTED THAT THE PATIENT HAD METALLOSIS-BLACKENED TISSUE AND SYNOVIUM. ADDITIONALLY, THE PATELLA WAS NOTED TO BE LOOSE, HELD IN BY SCAR TISSUE AND ALL THREE (3) PEGS HAD BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591142 REGENEREX 3 PEG SERIES A PATELLA 31MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 561750 00880304554412

    Patients

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