BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-225

    MDR report key: 4123293 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03631
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K040734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO RESTORATION MODULAR PROXIMAL BODY MALPOSITION WAS REPORTED. THE EVENT WAS CONFIRMED THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. A REVIEW OF THE PROVIDED RECORDS BY A CLINICAL CONSULTANT CONCLUDED: "THE REVISION SURGERY WAS PERFORMED FOR A DESCRIBED MALPOSITION OF THE FEMORAL COMPONENT AND WAS NOT RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS." CONCLUSIONS: THE REPORTED EVENT WAS CONFIRMED HOWEVER THE ROOT CAUSE OF THE MALPOSITIONED PROXIMAL BODY COMPONENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ALIGNMENT OF THE DEVICE IS THE RESPONSIBILITY OF THE OPERATING SURGEON, NO DEFICIENCIES OF THE DEVICE ITSELF WERE ALLEGED IN THE REPORTED EVENT. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNK PROX. BODY COMPONENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR HAD A RE-REVISION OF RESTORATION MODULAR STEM ON (B)(6) 2014 DUE TO INCORRECT VERSION OF THE PROX. BODY COMPONENT. THE PLANNED PROCEDURE WAS TO DISASSEMBLE THE PROX. BODY PART BY USING THE BODY/STEM SEPARATOR INSTRUMENT. LOCKING BOLT WAS REMOVED PRIOR TO INSERTING THE SEPARATOR INSTRUMENT IN TO THROUGH THE PROX BODY PART IN NORMAL FASHION. WHEN JACKSCREW WAS THREADED/TURNED WITH T-HANDLE IT SUDDENLY BECAME LOOSE AND THE SURGEON REALIZED THE JACKSCREW HAD BROKEN. SURGEON WAS NOT ABLE TO DISASSEMBLE THE SEPARATOR, SO HE HAD TO CUT THE SEPARATOR FROM THE SHOULDER LEVEL OF THE PROX. BODY. THIS WAS DONE BY USING HIGH SPEED BURR (SEBOTOME). THE COLLET AND THE DISTAL PART OF THE JACKSCREW WERE LEFT INSIDE THE CONE (BODY) BECAUSE IT COULD NOT BE REMOVED. A PIECE OF BONE CEMENT WAS PLACED ON TOP OF THE BODY BOLT HOLE TO HOLD THE PIECE OF THE COLLET/JACKSCREW FROM MOVING INSIDE THE BODY. THE INCORRECT VERSION WAS FIXED ON THE ACETABULAR (CUP) SIDE BUT THE INCORRECT ANTEVERSION ON STEM SIDE WAS NOT FIXED DUE TO BREAKAGE OF THE SEPARATOR. THIS MEANS THAT THERE MAY BE AN ADDITIONAL REVISION EXPECTED IN THE FUTURE IF THE CHANGES IN THE CUP POSITIONS ARE NOT ENOUGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR HAD A RE-REVISION OF RESTORATION MODULAR STEM ON 2.9.2014 DUE TO INCORRECT VERSION OF THE PROX. BODY COMPONENT. THE PLANNED PROCEDURE WAS TO DISASSEMBLE THE PROX. BODY PART BY USING THE BODY/STEM SEPARATOR INSTRUMENT. LOCKING BOLT WAS REMOVED PRIOR TO INSERTING THE SEPARATOR INSTRUMENT IN TO THROUGH THE PROX BODY PART IN NORMAL FASHION. WHEN JACKSCREW WAS THREADED/TURNED WITH T-HANDLE IT SUDDENLY BECAME LOOSE AND THE SURGEON REALIZED THE JACKSCREW HAD BROKEN. SURGEON WAS NOT ABLE TO DISASSEMBLE THE SEPARATOR, SO HE HAD TO CUT THE SEPARATOR FROM THE SHOULDER LEVEL OF THE PROX. BODY. THIS WAS DONE BY USING HIGH SPEED BURR (SEBOTOME). THE COLLET AND THE DISTAL PART OF THE JACKSCREW WERE LEFT INSIDE THE CONE (BODY) BECAUSE IT COULD NOT BE REMOVED. A PIECE OF BONE CEMENT WAS PLACED ON TOP OF THE BODY BOLT HOLE TO HOLD THE PIECE OF THE COLLET/JACKSCREW FROM MOVING INSIDE THE BODY. THE INCORRECT VERSION WAS FIXED ON THE ACETABULAR (CUP) SIDE BUT THE INCORRECT ANTEVERSION ON STEM SIDE WAS NOT FIXED DUE TO BREAKAGE OF THE SEPARATOR. THIS MEANS THAT THERE MAY BE AN ADDITIONAL REVISION EXPECTED IN THE FUTURE IF THE CHANGES IN THE CUP POSITIONS ARE NOT ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602849 25MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-225 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 35717201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention