BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY/STEM SEPARATOR

    MDR report key: 4123309 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03632
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED JACKSCREW SUBCOMPONENT OF A RESTORATION MODULAR STEM BODY SEPARATOR WAS REPORTED. THE EVENT WAS CONFIRMED. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED WITH A FRACTURED JACKSCREW SUBCOMPONENT, CONFIRMING THE REPORTED EVENT. MATERIAL ANALYSIS DETERMINED THE FRACTURE OCCURED DUE TO TORSIONAL OVERLOAD AND FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS ON THE SURFACES EXAMINED. -DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES -COMPLAINT HISTORY REVIEW FOUND THERE HAVE BEEN OTHER SIMILAR EVENTS FOR THE MANUFACTURING LOT AND PRODUCT FAMILY, A TREND REQUEST HAS BEEN SUBMITTED. CONCLUSIONS: THE DEVICE FRACTURED FROM TORSIONAL OVERLOAD, INDICATING AN EXCESSIVE FORCE WAS APPLIED TO THE JACKSCREW. MATERIAL ANALYSIS FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS ON THE SURFACES EXAMINED.

    Description of Event or Problem · 1

    ADDITIONALLY REPORTED ON 9/11/2014 VIA EMAIL : THE DISTAL PART OF THE JACKSCREW CAME OUT AFTER MD (B)(6) HAD CUT THE SEPARATOR FROM THE SHOULDER LEVEL OF THE PROXIMAL BODY. THE ONLY PART LEFT INSIDE THE CONE (BODY) IS THE PIECE OF COLLET. ADDITIONALLY INFORMATION VIA EMAIL RESPONSE TO THIRD REQUEST: THE CUP WAS REVISED BUT IT WAS COMPETITOR PRODUCT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602502 BODY/STEM SEPARATOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TACF80M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other