BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 38MM +5HW LNR

    MDR report key: 9311954 · Received November 12, 2019

    Report

    Report Number
    0001825034-2019-05122
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    July 1, 2013
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    PMA / PMN Number
    K100048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PT-106058- REGEN/RNGLC+ MULTI- 587490, 11-173663- M2A 38MM MOD HD- 005910, 103533- TI LOW PROFILE SCREW- 366080, 103538- TI LOW PROFILE SCREW- 170890, 103535- TI LOW PROFILE SCREW- 199290, 31-323230-RNGLC+ ACET DRL BIT- 466490, 31-323240-RNGLC+ ACET DRL BIT- 572480. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -05121, 0001825034 -2019 -05124. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASON; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102372 E-POLY 38MM +5HW LNR PROSTHESIS, HIP OIY ZIMMER BIOMET, INC. NI 933920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R