BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ24

    MDR report key: 7122518 · Received December 15, 2017

    Report

    Report Number
    0001825034-2017-11237
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    October 22, 2014
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. INITIAL OP NOTES DATED (B)(6) 2014 WERE REVIEWED AND NO COMPLICATIONS WERE NOTED. REVISION OP NOTES DATED (B)(6) 2014 WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO PAIN, SWELLING AND INFECTION. ALL THE COMPONENTS WERE REMOVED AND IMPLANTED WITH SPACERS. THE PATIENT WAS MARKED WITH ELEVATED LABS. EXTENDED TROCHANTERIC OSTEOTOMY PERFORMED DUE TO DIFFICULTY REMOVING THE FEMORAL STEM WITH FLEXIBLE OSTEOTOMES. DEPUY SPACES WERE IMPLANTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: RANAWAT/BURSTEIN ACETABULAR SHELL P/N 11-106054 L/N 085590; BIOLOX-DELTA MODULAR CERAMIC HEAD P/N 12-115120 L/N 103360; E1 RINGLOC MAX-ROM ACETABULAR LINER; TAPERLOC P/N 51-145090 L/N 299662, 51-145090 TPRLC XR MP T1 PPS 9 X 102.5 MM LOT 2996622. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 1

    PATIENT'S OPERATIVE REPORTS WERE RECEIVED WHICH REVEALED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FOUR MONTHS POST-IMPLANTATION DUE TO PAIN, SWELLING, AND INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR ANTIBIOTIC CEMENT SPACER.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT RECEIVED A REVISION PROCEDURE ONE YEAR POST-IMPLANTATION DUE TO PAIN, COBALT AND CHROMIUM CORRODE, AND WEAR FROM THE SURFACES OF THE ACETABULAR CUP, FEMORAL HEAD, AND TAPER SLEEVE. POST-SURGICAL PATHOLOGY REPORTS INDICATED THAT THE ACETABULAR HEAD AND LINING WERE SURROUNDED BY FIBRO CONNECTIVE TISSUE AND BONE WITH NECROSIS, GRANULATION, ACUTE AND CHRONIC INFLAMMATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900985 EPOLY 36MM RLC LNR MROM SZ24 HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 250530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R