BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 6118111 · Received November 21, 2016

    Report

    Report Number
    0002249697-2016-03704
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 22, 2016
    Report Date
    January 21, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A DISASSOCIATION BETWEEN THE CERAMIC HEAD AND ADM LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: VISUAL INSPECTION: A VISUAL INSPECTION WAS CARRIED OUT OF THE PROVIDED PHOTO OF THE IMPLANT WHICH NOTED THAT THERE WAS EXPLANTATION DAMAGE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS CARRIED OUT ON THE RETURNED PART WHERE IS WAS NOTED THAT: "THE RETURNED DEVICE WAS RE-INSPECTED AND FOUND TO BE FAILING FOR "A SPHERE DIAMETER", "TRUE POSITION OF INNER SPHERE", "B DIAMETER" AND "D DIMENSION" ABOVE THEIR RESPECTIVE UPPER TOLERANCES. A REVIEW OF THE ORIGINAL DHR CONFIRMED THAT THE B DIAMETER AND D DIMENSION OF THE RETURNED DEVICE WERE IN SPECIFICATION AT THE TIME OF MANUFACTURE. (THE B DIAMETER AND D DIMENSION ARE CHECKED ON 100% OF PARTS DURING IN-PROCESS INSPECTION). IT IS LIKELY THAT THE ASSEMBLY AND DISASSOCIATION OF THE LINER AND FEMORAL HEAD RESULTED IN THE B DIAMETER AND D DIMENSION GOING OUT OF SPECIFICATION." "THE FAILURE OF THESE FEATURES AND THE DAMAGE OBSERVED ON THE INNER SPHERE ARE DEEMED TO BE CONSISTENT WITH THE DISASSOCIATION OF THE FEMORAL HEAD FROM THE ADM LINER" - MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: "GIVEN THE COMPLEX CUP MALPOSITION, PRINCIPAL FAILURE MODE IS PROCEDURE-RELATED BECAUSE THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT POSITION." - DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. - COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A CLINICAL REVIEW CONCLUDED "GIVEN THE COMPLEX CUP MALPOSITION, PRINCIPAL FAILURE MODE IS PROCEDURE-RELATED BECAUSE THE SURGEON IS RESPONSIBLE FOR OPTIMAL COMPONENT POSITION." NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME, IF FURTHER INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE HIP JOINT, IT WAS OBSERVED THAT THE HEAD WAS DISASSOCIATED FROM THE MDM/ADM POLY LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE HIP JOINT, IT WAS OBSERVED THAT THE HEAD WAS DISASSOCIATED FROM THE MDM/ADM POLY LINER. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A REVISION HIP ARTHROPLASTY FOR A DISLOCATED HIP AFTER A FAILED ATTEMPT OF A CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768305 RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH 42524101

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention