BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP FMRL 7.5MM

    MDR report key: 5770298 · Received July 5, 2016

    Report

    Report Number
    0001825034-2016-02481
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    November 25, 2015
    Report Date
    January 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK050441
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01038 / 01039 / 02480 / 02481). NOT RETURNED BY ATTORNEY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTED INFORMATION - IMPLANT DATE TO (B)(6) 2009. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. VISUAL INSPECTION OF THE PRODUCT COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THIS DEVICE IS USED FOR TREATMENT. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUE NOTED: 14-103202 LOT 982130 AND 139254 LOT 368110. COMPLAINT HISTORY FOR METAL ON METAL COMPLAINTS IS REVIEWED. MEDICAL RECORDS STATED: COLD-WELDED MONOBLOCK COBALT-CHROME HEAD TO FEMORAL COMPONENT. HOWEVER, THE DEVICE STATED AS A HEAD IS ACTUALLY THE TAPER ADAPTOR WHICH SEIZED ONTO THE STEM TAPER INTERFACE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 1

    OPERATIVE NOTES INDICATED THAT DURING A LEFT HIP REVISION, THE HEAD COLD-WELDED TO THE STEM AND COULD NOT BE SEPARATED; AFTER MULTIPLE ATTEMPTS TO SEPARATE THE HEAD FROM THE STEM AN EPISIOTOMY WAS PERFORMED AND THE STEM WAS REMOVED ALONG WITH THE HEAD.

    Description of Event or Problem · 1

    THE SPIKED MAGNUM CUP BECAME LOOSE DUE TO THE REPETITIVE IMPACTIONS. SINCE THE HEAD COULD NOT BE REMOVED AFTER MULTIPLE ATTEMPTS A EPISIOTOMY WAS PERFORMED AND THE STEM WAS REMOVED. THE LENGTH OF DELAY WAS REPORTED AS 1.5 HOURS. REVIEW OF THE OP NOTES DETERMINED THAT THE DEVICE STATED AS A HEAD IS ACTUALLY THE TAPER ADAPTOR WHICH SEIZED ONTO THE STEM TAPER INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422625 TAPERLOC MICROP FMRL 7.5MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 982130

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention