BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COCR FEMORAL HEAD

    MDR report key: 7313686 · Received March 5, 2018

    Report

    Report Number
    0001825034-2018-01649
    Event Type
    Injury
    Date Received
    March 5, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS DEVICES REMAIN IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# 16-104150, RINGLOC SHELL, LOT# 847500, ITEM# EP-108323, E-POLY LINER, LOT# 301360, ITEM# 14-103201, TAPERLOC STEM, LOT # 606010. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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. MULTIPLE REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00376-1, 0001825034-2018-00377-1, 00018.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01649-1, 0001825034-2018-00377-2, 0001825034-2018-00376-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT STARTED EXPERIENCING PAIN 4 YEARS POST IMPLANTATION. THE PATIENT IS EXPERIENCING WORSENING PAIN, A LIMP, AMBULATION DIFFICULTIES, MUSCLE SPASMS, MUSCLE DAMAGE, AND NUMBNESS FROM HIP DOWN TO TOES FOR THE PAST 2 YEARS. PATIENT ALSO ALLEGES THAT THE HIP "TRIED TO DISLOCATE" ON TWO OCCASIONS. PATIENT REPORTS BEING PRESCRIBED PERCOCET FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158236 BIOMET COCR FEMORAL HEAD HIP PROTHESIS JDI ZIMMER BIOMET, INC. N/A 047130 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other