BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 5018473 · Received August 20, 2015

    Report

    Report Number
    2648920-2015-00312
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 1, 2014
    Report Date
    December 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION WITH NO DEVIATIONS OR ANOMALIES. THESE REPORTED DEVICES ARE USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THESE DEVICES WAS REVIEWED AND FOUND NO PREVIOUS COMPLAINTS FOR EACH RESPECTIVE LOT. THE DEVICES USED ARE AN APPROVED AND COMPATIBLE COMBINATION. IMPLANTATION AND REVISION OPERATIVE NOTES WERE REVIEWED. IT WAS NOTED THAT THE PATIENT'S COBALT AND CHROMIUM LEVELS WERE TAKEN AND WERE NORMAL. ADDITIONALLY, THE NOTES STATE THAT THERE WAS A BLACK DISCOLORATION ON THE SURFACE OF THE MATING PORTIONS OF THE HEAD-STEM TAPER JUNCTION; MACHINING MARKS WERE ALSO VISIBLE. A DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED CORROSION CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #00784301536, VERSYS FEMORAL STEM, LOT #601170250- REMAINS IMPLANTED. MANUFACTURED BY ZIMMER INC. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. TRILOGY F/M ACET SHELL 56 OD CLUST P/N 00620005622 L/N 61439159. TRILOGY BONE SCREW 6.5X40 P/N 00625006540 L/N 61445405. TRILOGY BONE SCREW 6.5X35 P/N 00625006535 L/N 61412743. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO ADVERSE LOCAL TISSUE REACTION AND CORROSION. OPERATIVE NOTES INDICATE THAT THERE WAS EVIDENCE OF PSEUDOTUMOR WHICH WAS DEBRIDED. THERE WAS ALSO DISLOCATION OF THE STEM AND HEAD.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552385 VERSYS FEMORAL HEAD JDI JDI ZIMMER, INC. 61495336

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R