BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY CONSTRAINED INSERT 52MM

    MDR report key: 3032235 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01181
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING AN ALL POLY CONSTRAINED INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED DEVICE WAS SUBSTANTIALLY DAMAGED. IT IS BELIEVED THIS DAMAGE OCCURRED DURING EXPLANTATION. MEDICAL RECORDS WERE NOT REVIEWED FOR THIS INVESTIGATION AS THEY WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE RETURNED DEVICE WAS TOO SEVERELY DAMAGED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON (NAME UNKNOWN) REPORTED VIA THE SALES REP, (B)(6), THAT A PATIENT REQUIRED A REVISION PROCEDURE OF THE CONSTRAINED ACETABULAR INSERT. THE SURGEON REPORTED THAT HE BELIEVES MINIMAL MOVEMENT CAUSED DISLOCATION AND THAT HE IS CONCERNED AS THIS IS A HEAVILY CONSTRAINED DEVICE. THE SURGEON REPORTED THAT THE DEVICE WILL BE MADE AVAILABLE FOR INVESTIGATION AND THAT UPON EXTRACTION, HE DID NOT IDENTIFY ANY OBVIOUS SIGNS OF FAILURE.

    Description of Event or Problem · 1

    THE SURGEON (NAME UNKNOWN) REPORTED VIA THE SALES REP, (B)(4), THAT A PATIENT REQUIRED A REVISION PROCEDURE OF THE CONSTRAINED ACETABULAR INSERT. THE SURGEON REPORTED THAT HE BELIEVES MINIMAL MOVEMENT CAUSED DISLOCATION AND THAT HE IS CONCERNED AS THIS IS A HEAVILY CONSTRAINED DEVICE. THE SURGEON REPORTED THAT THE DEVICE WILL BE MADE AVAILABLE FOR INVESTIGATION AND THAT UPON EXTRACTION, HE DID NOT IDENTIFY ANY OBVIOUS SIGNS OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136126 ALL POLY CONSTRAINED INSERT 52MM IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MLL0NM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention