BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/58

    MDR report key: 3781413 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01566
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 DISLOCATION INVOLVING A RESTORATION ADM INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: ECCENTRIC POSITION OF HEAD INTO ACETABULUM AND DISSOCIATED NOTED ON X-RAY. NEED OP REPORTS, CLINICAL HISTORY AND PROGRESS NOTES TO FULLY INVESTIGATE. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. DURING THE MANUFACTURE OF THIS LOT NCR C10-0050 WAS REFERENCED TO ADD AN INSPECTION STEP TO THE MANUFACTURING PROCESS AND IT HAD NO EFFECT ON THE FIT, FORM OR FUNCTION OF THE DEVICE. COMPLAINT HISTORY REVIEW: THERE HAS BEEN ONE OTHER SIMILAR EVENT FOR THE LOT REFERENCED. (B)(4) WAS OPENED TO INVESTIGATE DISLOCATION. (B)(4) CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS THE OPERATIVE REPORTS, PROGRESS NOTES AND CLINICAL HISTORY AS WELL AS PRODUCT RETURN ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A RESTORATION ADM INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED ECCENTRIC POSITION OF HEAD INTO ACETABULUM AND DISSOCIATED NOTED ON X-RAY. THE EVENT COULD NOT BE CONFIRMED. NEED OP REPORTS, CLINICAL HISTORY AND PROGRESS NOTES. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE PATIENT "FELL OFF THEIR TRACTOR" AND THE PATIENT HAD PAIN IN THEIR HIP. X-RAY SHOWED A POTENTIAL CHANGE IN THE HEAD POSITION OF THE TOTAL HIP PROSTHESIS. THE PATIENT WAS SCHEDULED FOR REVISION HIP SURGERY. DURING REVISION HIP SURGERY (B)(6) 2014, IT WAS FOUND THAT THE METAL HEAD WAS DISLOCATED FROM THE X3 MDM INSERT. A NEW METAL HEAD AND X3 MDM INSERT WERE ASSEMBLED AND IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE PATIENT "FELL OFF THEIR TRACTOR" AND THE PATIENT HAD PAIN IN THEIR HIP. X-RAY SHOWED A POTENTIAL CHANGE IN THE HEAD POSITION OF THE TOTAL HIP PROSTHESIS. THE PATIENT WAS SCHEDULED FOR REVISION HIP SURGERY. DURING REVISION HIP SURGERY (B)(6) 2014 IT WAS FOUND THAT THE METAL HEAD WAS DISLOCATED FROM THE X3 MDM INSERT. A NEW METAL HEAD AND X3 MDM INSERT WERE ASSEMBLED AND IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE PATIENT "FELL OFF THEIR TRACTOR" AND THE PATIENT HAD PAIN IN THEIR HIP. X-RAY SHOWED A POTENTIAL CHANGE IN THE HEAD POSITION OF THE TOTAL HIP PROSTHESIS. THE PATIENT WAS SCHEDULED FOR REVISION HIP SURGERY. DURING REVISION HIP SURGERY (B)(6) 2014 IT WAS FOUND THAT THE METAL HEAD WAS DISLOCATED FROM THE X3 MDM INSERT. A NEW METAL HEAD AND X3 MDM INSERT WERE ASSEMBLED AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260122 RESTORATION ADM X3 INS 28/58 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 38054701

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R