BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE MICROPLASTY STEM

    MDR report key: 6714129 · Received July 14, 2017

    Report

    Report Number
    0001825034-2017-04673
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    June 13, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-165230 910750 RING LOC BI-POLAR ACETABULAR CUP 28 MM I.D. / 53 MM O.D., 163638 488360 MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017- 04706 AND 0001825034-2017-04708.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. THE X-RAY REVIEW REPORT STATED THAT THE ACETABULAR CUP DEMONSTRATES A DECREASED LATERAL INCLINATION ANGLE. THIS COULD BE A SOURCE OF PATIENT PAIN/DISCOMFORT. ALTHOUGH THE PROVIDED SUMMARY INDICATES CONCERN FOR INSTABILITY OF THE FEMORAL STEM, THERE IS NO RADIOGRAPHIC PROOF OF THIS POSSIBILITY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S HIP WAS REVISED APPROXIMATELY 8 MONTH'S POST-IMPLANTATION DUE TO PAIN AND STEM MIGRATION. ALL IMPLANTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496720 TAPERLOC COMPLETE MICROPLASTY STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3587045

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R