BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR +3MM NECK

    MDR report key: 6716803 · Received July 17, 2017

    Report

    Report Number
    0001825034-2017-04971
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    July 25, 2017
    Report Date
    May 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: EP-043250 RLOC-X E-POLY STD 50/32MM UK 3598976; 131350BM EXCEED ABT RNGL-X SHL BMPC D50 3776712 ; 09309-0-112 EXETER 2.5MM INTRAMEDULLARY PLUG V31SDL8145. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE HEAD SHOWS VERY LITTLE SIGNS OF WEAR. THE LOT AND SIZE ETCH ARE CLEARLY VISIBLE ON THE CHAMFERED EDGE. THERE IS ONE LARGE SCRATCH AND A SCUFF ON THE ARTICULATING SURFACE NEAR THE CHAMFER EDGE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DETERMINED TO BE USER ERROR. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). CONCOMITANT PRODUCTS - EP-043250 RLOC-X E-POLY STD 50/32MM UK 3598976; 131350BM EXCEED ABT RNGL-X SHL BMPC D50 3776712.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). (B)(6). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A TRAUMA PROCEDURE THE PATIENT WAS IMPLANTED WITH MIX MATCH HIP IMPLANT. THE STEM WAS FROM A COMPETITOR AND HAD A DIFFERENT TRUNION GEOMETRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE THE PATIENT WAS IMPLANTED WITH INCOMPATIBLE HIP IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS INITIALLY IMPLANTED OFF LABEL IN CONJUNCTION WITH INCOMPATIBLE COMPETITOR DEVICES ON THE RIGHT SIDE, CAUSING THE NEED FOR REVISION TO IMPLANT COMPATIBLE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497877 32MM MOD HEAD COCR +3MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 00J3402292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R STRYKER CEMENTED STEM