BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH MULTI HOLES POROUS

    MDR report key: 6959565 · Received October 18, 2017

    Report

    Report Number
    0001822565-2017-07238
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    April 19, 2014
    Report Date
    November 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). CONCOMITANT PRODUCT(S): - 0106010001 AVENIR® MüLLER, STEM, STANDARD, 4021843. A 00625006540 BONE SCR 6.5X40 SELF-TAP 62460749. A 00625006520 BONE SCR 6.5X20 SELF-TAP 62640321. A 00662406520 BONE SCREW SELF-TAPPING 62603033. A 00662406525 BONE SCREW SELF-TAPPING 62326385. A 00662406525 BONE SCREW SELF-TAPPING. A 00662406530 BONE SCREW SELF-TAPPING 62490818. A 00625006525 BONE SCR 6.5X25 SELF-TAP 62528844. A 00489400158 TRABECULAR METAL¿¢ ACETABULAR 61528297. A 00625006520 BONE SCR 6.5X20 SELF-TAP 62466429. A 00489400115 TRABECULAR METAL ¿¢ ACETABULAR 62319561. (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ACCORDING TO THE OPERATIVE NOTES; THE ILIAC ARTERY WAS FOUND TO HAVE STENOSIS AND PALPABLY THROMBOSED. THE PATIENT'S FOOT WAS FORCED IN PLANTARFLEXION. HER CALF WAS EXTREMELY TAUT AND PAINFUL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EMERGENCY PROCEDURE DUE TO PLANTARFLEXION 2 HOURS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737308 SHELL WITH MULTI HOLES POROUS PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62509815

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R