BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 32MM +3 MAXROM LNR SZ22

    MDR report key: 6980940 · Received October 26, 2017

    Report

    Report Number
    0001825034-2017-09634
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 29, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PRODUCTS: 103530, RINGLOC TI LOW PROFILE SCREW, 149080. 010000994, G7 APICAL HOLE PLUG, 3979400. PT-116048, REGEN/RNGLC+ LTD 48MM SZ 22, 333290. 12-115114, CERAMIC BIOLOX DELTA MODULAR HEAD, 2889438. 51-108040, TAPERLOC 133 MICROPLASTY TYPE1, 3920624. CUSTOMER HAS BEEN 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 09632, 0001825034 - 2017 - 09633, 0001825034 - 2017 - 09631, 0001825034 - 2017 - 09635, 0001825034 - 2017 - 09636.REQUESTED BUT NOT RETURNED BY HOSPITAL

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761199 E-POLY 32MM +3 MAXROM LNR SZ22 PROSTHESIS, HIP MAY ZIMMER BIOMET, INC. N/A 274340

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R SEE H10 NARRATIVE