BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/52

    MDR report key: 3243735 · Received July 23, 2013

    Report

    Report Number
    0002249697-2013-02414
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS REPORTED FOR A RESTORATION ADM X3 INS 28/52. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT RECEIVED THA ON (B)(6) 2013, AT THE HOSPITAL. THE FOLLOWING IMPLANTS WERE USED. TRITANIUM CUP, ACCLOADE II STEM, MDM LINER AND INSERT, AND V40 LIFT HEAD. THE HIP WAS OPERATED ON AND THERE WERE DIFFICULTIES DURING SURGERY WITH CUP PLACEMENT SINCE THE PATIENT WAS SO LARGE. THIS PATIENT IS VERY HEAVY (+(B)(6)), NOT COMPLIANT AND HIS MUSCLES ARE VERY TIGHT DUE TO PAST HIP AND BACK PROBLEMS. A PSL CUP WAS FIRST INSERTED AND CHANGED TO A TRITANIUM CUP WITH MDM LINER AND INSERT. THE PATIENT WAS PUT THROUGH A RANGE OF MOTION AND SURGEON WAS HAPPY WITH THE RESULTS. REHAB WAS MOVING ALONG AS SCHEDULED BUT THE PATIENT WAS NOT COMPLIANT AND WAS REFUSING TO GET OUT OF BED FOR HIS PT. ON (B)(6), 2013, THE THERAPIST PULLED ON HIS LEG AS HE WAS GETTING UP OUT OF BED AND THE PATIENT FELT A POP AND PAIN IN HIS HIP. THE SURGEON TOOK THE PATIENT BACK TO THE OR AFTER X-RAYS SHOWED A DISLOCATION OF THE MDM INSERT FROM THE MDM LINER. THE SURGEON OPENED HIM UP AND REDUCED THE HIP AND AFTER A RANGE OF MOTION HE FELT THE HIP WAS STABLE BUT DECIDED TO INCREASE THE HEAD LENGTH FROM +4MM TO +8MM AND A NEW MDM INSERT. THE DOCTOR FELT COMFORTABLE WITH THIS RANGE OF MOTION AND TIGHTNESS. HE CLOSED THE PATIENT. UPON EXAMINING THE MDM INSERT AND LIFT 28MM HEAD, IT SHOWED NO DEFECT OR SEPARATION.

    Description of Event or Problem · 1

    PATIENT RECEIVED THA ON (B)(6)-2013 AT (B)(6) HOSPITAL. THE FOLLOWING IMPLANTS WERE USED. TRITANIUM CUP, ACCLOADE II STEM, MDM LINER AND INSERT, AND V40 LFIT HEAD. THE HIP WAS OPERATED ON AND THERE WERE DIFFICULTIES DURING SURGERY WITH CUP PLACEMENT SINCE THE PATIENT WAS SO LARGE. THIS PATIENT IS VERY HEAVY (+(B)(6)), NOT COMPLIANT AND HIS MUSCLES ARE VERY TIGHT DUE TO PAST HIP AND BACK PROBLEMS. A PSL CUP WAS FIRST INSERTED AND CHANGED TO A TRITANIUM CUP WITH MDM LINER AND INSERT. THE PATIENT WAS PUT THROUGH A RANGE OF MOTION AND SURGEON WAS HAPPY WITH THE RESULTS. REHAB WAS MOVING ALONG AS SCHEDULED BUT THE PATIENT WAS NOT COMPLIANT AND WAS REFUSING TO GET OUT OF BED FOR HIS PT. ON (B)(6), 2013 THE THERAPIST PULLED ON HIS LEG AS HE WAS GETTING UP OUT OF BED AND THE PATIENT FELT A POP AND PAIN IN HIS HIP. THE SURGEON TOOK THE PATIENT BACK TO THE OR AFTER X-RAYS SHOWED A DISLOCATION OF THE MDM INSERT FROM THE MDM LINER. THE SURGEON OPENED HIM UP AND REDUCED THE HIP AND AFTER A RANGE OF MOTION HE FELT THE HIP WAS STABLE BUT DECIDED TO INCREASE THE HEAD LENGTH FROM +4MM TO +8MM AND A NEW MDM INSERT. THE DOCTOR FELT COMFORTABLE WITH THIS RANGE OF MOTION AND TIGHTNESS. HE CLOSED THE PATIENT. UPON EXAMINING THE MDM INSERT AND LFIT 28MM HEAD, IT SHOWED NO DEFECT OR SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342151 RESTORATION ADM X3 INS 28/52 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 38249001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R