BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 6736536 · Received July 24, 2017

    Report

    Report Number
    0002648920-2017-00460
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    May 5, 2014
    Report Date
    November 28, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK95337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 MEDICAL PRODUCTS - 0106010001 AVENIR® MÃLLER, STEM, 4021843. THE 00489400158 TRABECULAR METAL ACETABULAR REVISION SYSTEM, BUTTRESS AUGMENT 62319561. THE 00489440000 TRABECULAR METAL ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, 61421724. THE 00489430000 TRABECULAR METAL ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS, 62091730. THE 00875706002 SHELL WITH MULTI HOLES POROUS 62509815. THE 00801803601 FEMORAL HEAD PRODUCT 62454687. THE 00875801436 CONSTRAINED LINER WITH RING 61730152. THE 00625006540 BONE SCREW 62460749. THE 00625006520 BONE SCREW 62640321. THE 00662406520 BONE SCREW 62603033. THE 00662406525 BONE SCREW 62326385. THE 00662406525 BONE SCREW 62395631. THE 00662406530 BONE SCREW 62490818. THE 00625006520 BONE SCREW 62466429. THE 00625006525 BONE SCREW 62528844. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-05098, 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517145 FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62454687

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R