BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY CONSTRAINED INSERT 50MM

    MDR report key: 3023957 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01133
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETERMINATION COULD BE MADE WITH THE LIMITED MEDICAL RECORDS PROVIDED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. CHR INDICATES THERE HAVE BEEN NO PREVIOUS REPORTED EVENTS FOR THIS LOT ID. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS LAYING IN BED AND DISLOCATED THE HIP FROM THE CONSTRAINED LINER.

    Description of Event or Problem · 1

    PATIENT WAS LAYING IN BED AND DISLOCATED THE HIP FROM THE CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126678 ALL POLY CONSTRAINED INSERT 50MM IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MKRND1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention