BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 54MM

    MDR report key: 7364614 · Received March 22, 2018

    Report

    Report Number
    0001825034-2018-01889
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR INVESTIGATION, AS THE SURGEON DID NOT APPROVE FOR RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM #650-1055 CER BIOLOXD OPTION HD 28MM LOT# 380520, ITEM# EP-200144 ACT ARTIC E1 HIP BRG 28X38MM LOT#483480. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-01887; 0001825034-2018-01888.

    Additional Manufacturer Narrative · 1

    CECONCOMITANT MEDICAL PRODUCTS: BIOLOXD OPTION HD 28MM CAT: 650-1055 LOT: 380520, ACT ARTIC E1 HIP BRG 28X38MM CAT: EP-200144 LOT: 843460, CER OPTION TYPE 1 TPR SLEVE -3 CAT: 650-1065 LOT: 255850, MLRY-HD POR FMRL 10X155MM CAT: 11-104110 LOT: 0066480. REPORTED EVENT WAS CONFIRMED FROM PHOTOGRAPHS RECEIVED. INTRAOPERATIVE PICTURES WERE RECEIVED. THE VISUAL INSPECTION OF THE PICTURES WAS PERFORMED WHICH EXHIBITS THE LINER FRACTURE WHICH LED TO THE WEAR BETWEEN HEAD AND THE CUP CREATING WEAR MARKS ON THE CERAMIC HEAD. BLACK DEBRIS IS OBSERVED WHICH INDICATES METALLOSIS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO FURTHER ACTION(S) IS/ARE REQUIRED. AS THE SHELL WAS NOT REMOVED DURING THE PATIENT'S FIRST REVISION PROCEDURE, THE BEARING AND SHELL ARE CONSIDERED OFF LABEL USE. HOWEVER IT IS UNKNOWN IF THIS HAS A DEFINITE RELATIONSHIP WITH THE REPORTED EVENT AND THEREFORE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION AFTER COMPLAINING OF PROGRESSIVE PAIN. DURING REVISION SURGERY IT WAS NOTED THAT THE BEARING WAS BROKEN AND THE CERAMIC HEAD HAD WORN ON THE INSIDE OF THE METAL SHELL CREATING METALLOSIS. FOLLOW UP ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207627 M2A-38 CUP NON FLARED SZ 54MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 458950

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R