BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 8834743 · Received July 28, 2019

    Report

    Report Number
    0001825034-2019-03265
    Event Type
    Injury
    Date Received
    July 28, 2019
    Date of Event
    August 13, 2016
    Report Date
    November 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS PRODUCT WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 3002806535-2019-00863.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS PRODUCT WAS REPORTED UNDER THE WRONG MFR NUMBER. THE EVENT WILL BE REPORTED ON 3002806535-2019-00863.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIV 2-HOLE SHL 56MM LNR SZ 24, PN 14-103656, LN 619240, EPOLY 36MM RLC LNR MROM SZ24, PN EP-105994, LN 882430, TPRLC 133 MP TYPE1 PPS SO 12.0, PN 51-106120, LN 3455265. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2019-03262, 0001825034-2019-03263, 0001825034-2019-03264. REPORT SOURCE: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS EXPERIENCED DEEP INFECTION APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628524 DELTA CERAMIC FEM HD 36/-3MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 2015080065

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other