BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023

    MDR report key: 2960979 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00670
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K040734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING DISLOCATION INVOLVING A RESTORATION MODULAR FEMORAL SYSTEM WAS REPORTED. THE EVENT WAS CONFIRMED. MATERIAL ANALYSIS OF THE RETURNED DEVICE FOUND EVIDENCE THE TAPER JUNCTION MAY NOT HAVE BEEN FULLY LOCKED AT THE TIME OF MANUFACTURE. NO MATERIAL OR MANUFACTURING DEFECTS WERE NOTED. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER EVENTS HAVE BEEN REPORTED FOR THE MANUFACTURING LOT. CLINICIAN REVIEW WAS REQUESTED FOR THE PROVIDED X-RAY IMAGES. THE REVIEW CONCLUDED: "BASED UPON THE MINIMAL CLINICAL INFORMATION AND MATERIAL ANALYSIS REPORT, THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION." CONCLUSION: THE REPORTED DISLOCATION WAS CONFIRMED. MATERIAL ANALYSIS INDICATED THE SUBJECT FEMORAL BODY COMPONENT MAY NOT HAVE BEEN FULLY LOCKED WITH THE STEM AT THE TIME OF IMPLANTATION. THIS FINDING COUPLED WITH THE REPORTED TRAUMA AFTER IMPLANTATION LIKELY RESULTED IN A CHANGE IN THE FEMORAL BODY VERSION WHICH CONTRIBUTED TO THE RECURRENT DISLOCATIONS EXPERIENCED BY THE PATIENT. SERIAL X-RAYS AND FOLLOWUP NOTES DETAILING THE TRAUMATIC EVENT AND SUBSEQUENT MONTHS PRIOR TO REVISION WOULD BE REQUIRED TO CONFIRM THIS CONCLUSION. MATERIAL ANALYSIS AND CLINICIAN REVIEW FOUND NO EVIDENCE THAT DEVICE MATERIAL OR MANUFACTURING FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RESTORATION MODULAR PROXIMAL BODY WAS LOOSE UPON REVISION FOR DISLOCATION. SCREW CAME OUT EASILY AS WELL. DATE OF ORIGINAL IMPLANTATION WAS (B)(6) 2012. SINCE THEN THE PATIENT DISLOCATED AT LEAST 4 TIMES. WHEN THE PROXIMAL BODY WAS INITIALLY IMPLANTED IT WAS IMPLANTED WITH ANTIVERSION. THE DEPTH TO SEAT CHECKER WAS USED AND THE TORQUE WRENCH WAS USED FOR IMPLANTATION. WHEN REVISED THE SURGEON WAS ABLE TO SPIN THE BODY AND THE SCREW CAME OUT EASILY. IT SHOULD BE NOTED THAT THE PATIENT AS DESCRIBED BY THE SURGEON DID FALL SHORTLY AFTER SURGERY.

    Description of Event or Problem · 1

    RESTORATION MODULAR PROXIMAL BODY WAS LOOSE UPON REVISION FOR DISLOCATION. SCREW CAME OUT EASILY AS WELL. DATE OF ORIGINAL IMPLANTATION WAS (B)(6) 2012. SINCE THEN THE PATIENT DISLOCATED AT LEAST 4 TIMES. WHEN THE PROXIMAL BODY WAS INITIALLY IMPLANTED IT WAS IMPLANTED WITH ANTIVERSION. THE DEPTH TO SEAT CHECKER WAS USED AND THE TORQUE WRENCH WAS USED FOR IMPLANTATION. WHEN REVISED THE SURGEON WAS ABLE TO SPIN THE BODY AND THE SCREW CAME OUT EASILY. IT SHOULD BE NOTED THAT THE PATIENT AS DESCRIBED BY THE SURGEON DID FALL SHORTLY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65977 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 38257502

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O| R