BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC GRIP WITH 2 CABLE

    MDR report key: 2925476 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00139
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    May 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LYT
    PMA / PMN Number
    K070170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER HIP.THE INFORMATION IN THIS REPORT WAS PROVIDED BY THE PATIENT WHO HAS RETAINED A LAWYER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING A REVISION DUE TO PAIN INVOLVING A TROCHANTERIC GRIP WITH 2 CABLE WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED OPERATIVE REPORTS, OFFICE NOTES, RADIOLOGY REPORTS, AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS, NO PATHOLOGY REPORT CONFIRMING THE DIAGNOSIS OF ALTR, AND NO MRI IMAGE OR REPORT OF ALTR TO REVIEW. THERE IS NO CONFIRMATION THAT THIS PATIENT¿S SYMPTOMS WERE DUE TO ALTR FROM THE STEM/NECK MODULAR JUNCTION CORROSION PRODUCTS. HER PERSISTENT TROCHANTERIC BURSITIS AND CHRONIC PAIN SYNDROME SUGGEST THAT THESE PROBLEMS MAY HAVE BEEN RESPONSIBLE FOR THE PATIENT¿S PRE-REVISION SYMPTOMS.¿ A CONVERSATION WITH THE CLINICAL CONSULTANT NOTED THAT THE CONCLUSION REFERS TO BOTH THE PATIENTS PRE AND POST REVISION SYMPTOMS. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THAT THE TROCHANTERIC BURSITIS AND CHRONIC PAIN SYNDOME MAY HAVE BEEN RESPONSIBLE FOR THE PATIENT¿S SYMPTOMS. ADDITIONALLY, THE REVIEW BY A CLINICAL CONSULTANT STATED THAT THE CAUSE OF THE PAIN IS LIKELY RELATED TO PATIENT FACTORS. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAD REVISION SURGERY IN (B)(6) 2012. AT THE TIME OF REVISION SURGERY, PATIENT HAD STAPLE SURGICALLY IMPLANTED TO HELP HOLD THE HIP IMPLANT. PATIENT IS REPORTING HAVING PAIN AND WILL HAVE STAPLE REMOVED. PATIENT STATES THAT SHE HAS RETAINED A LAWYER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAD REVISION SURGERY IN (B)(6) 2012. AT THE TIME OF REVISION SURGERY, PATIENT HAD STAPLE SURGICALLY IMPLANTED TO HELP HOLD THE HIP IMPLANT. PATIENT IS REPORTING HAVING PAIN AND WILL HAVE STAPLE REMOVED. PATIENT STATES THAT SHE HAS RETAINED A LAWYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30703 TROCHANTERIC GRIP WITH 2 CABLE IMPLANT LYT STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention