BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 4131069 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00458
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. PRODUCT DETAILS: UNKNOWN 65 ASNIS SCREW.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. BASED ON CURRENTLY AVAILABLE INFORMATION THE REPORTED EVENT APPEARS TO BE MOST LIKELY DEVICE UNRELATED CLINICALLY ISSUE. AS PER IFUS ( SEE ORIGINAL STATEMENT), THE REPORTED AVASCULAR NECROSIS IS A COMMON COMPLICATION OF THE ORIF ITSELF. ADDITIONALLY, AS PER OPERATIVE TECHNIQUE (SEE ORIGINAL STATEMENT ), THE SURGEON HAS TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT OPTION. IN THIS CASE, CONSIDERING THE REPORTED STATEMENT ¿THE SURGEON EXPLANTED THE SCREWS AND CONVERTED TO A HIP BIPOLAR CUP DUE TO THE AVASCULAR NECROSIS¿ AN USER RELATED ISSUE DUE TO AN INADEQUATE DEVICE SELECTION CANNOT COMPLETELY BE EXCLUDED NOR CONFIRMED. HOWEVER, MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. SHOULD ADDITIONALLY INFORMATION BE RECEIVED THE COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION RESULTS REASSESSED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. IFUS [ORIGINAL STATEMENT]: " IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EFFECTS INVOLVING THE USE OF INTERNAL FRACTURE FIXATION DEVICES: ¿ DELAYED UNION OR NON-UNION OF THE FRACTURE SITE. THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NONUNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE. CONDITIONS ATTRIBUTABLE TO NON-UNION, OSTEOPOROSIS, OSTEOMALACIA, DIABETES, INHIBITED REVASCULARIZATION AND POOR BONE FORMATION CAN CAUSE LOOSENING, BENDING, CRACKING FRACTURE OF THE DEVICE OR PREMATURE LOSS OF RIGID FIXATION WITH THE BONE. IMPROPER ALIGNMENT CAN CAUSE A MAL-UNION OF THE BONE AND/OR BENDING, CRACKING OR EVEN BREAKAGE OF THE DEVICE. INCREASED FIBROUS TISSUE RESPONSE AROUND THE FRACTURE SITE DUE TO UNSTABLE COMMINUTED FRACTURES. EARLY OR LATE INFECTION, BOTH DEEP OR SUPERFICIAL. DEEP VENOUS THROMBOSIS. AVASCULAR NECROSIS. SHORTENING OF THE EFFECTED BONE/FRACTURE SITE. SUBCLINICAL NERVE DAMAGE MAY POSSIBLY OCCUR AS A RESULT OF THE SURGICAL TRAUMA. MATERIAL SENSITIVITY REACTIONS IN PATIENTS FOLLOWING SURGICAL IMPLANTATION HAVE RARELY BEEN REPORTED, HOWEVER THEIR SIGNIFICANCE AWAITS FURTHER CLINICAL EVALUATION. ¿OPERATIVE TECHNIQUE [ORIGINAL STATEMENT]: " CONTRAINDICATIONS THE PHYSICIAN¿S EDUCATION, TRAINING AND PROFESSIONAL JUDGMENT MUST BE RELIED UPON TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT OPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP. SURGEON CONVERTED TO BIPOLAR HEAD DUE TO AVN. ONLY THE ASNINS SCREW WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP. SURGEON CONVERTED TO BIPOLAR HEAD DUE TO AVN. ONLY THE ASNINS SCREW WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612595 UNKNOWN_OSTEOSYNTHESIS_PRODUCT IMPLANT HWC STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1