BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X25 SELF-TAP

    MDR report key: 6736574 · Received July 24, 2017

    Report

    Report Number
    0002648920-2017-00468
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    May 5, 2014
    Report Date
    December 11, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    PK934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). 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. CONCOMITANT PRODUCT(S) - A 0106010001 AVENIR® MüLLER, STEM, 4021843. A 00489400158 TRABECULAR METAL¿¢ ACETABULAR REVISION SYSTEM, BUTTRESS AUGMENT 62319561. A 00489440000 TRABECULAR METAL ¿¢ ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, 61421724. A 00489430000 TRABECULAR METAL¿¢ ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, 62091730. A 00875706002 SHELL WITH MULTI HOLES POROUS 62509815. A 00801803601 FEMORAL HEAD PRODUCT 62454687. A 00875801436 CONSTRAINED LINER WITH RING 61730152. A 00625006540 BONE SCREW 62460749. A 00625006520 BONE SCREW 62640321. A 00662406520 BONE SCREW 62603033. A 00662406525 BONE SCREW 62326385. A 00662406525 BONE SCREW 62395631. A 00662406530 BONE SCREW 62490818. A 00625006520 BONE SCREW 62466429. A 00625006525 BONE SCREW 62528844. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05098, 0002648920-2017-00460, 0001822565-2017-05103, 0002648920-2017-00461, 0002648920-2017-00462, 0002648920-2017-00463, 0002648920-2017-00464, 0002648920-2017-00465, 0002648920-2017-00466, 0002648920-2017-00467 & 0002648920-2017-00468.

    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 WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DOCUMENTATION SHOWS THE LOT WAS STERILIZED ACCORDING TO SPECIFICATIONS. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT THE PATIENT'S LEFT LEG WAS AMPUTATED APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO NECROSIS AND INFECTION FOLLOWING A THROMBECTOMY. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED HALLUCINATIONS FOR 20 DAYS FOLLOWING THE THROMBECTOMY.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517566 BONE SCR 6.5X25 SELF-TAP PROSTHESIS, HIP MRA ZIMMER MANUFACTURING B.V. N/A 62528844

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R