BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/54

    MDR report key: 3945440 · Received July 21, 2014

    Report

    Report Number
    0002249697-2014-02808
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DISASSOCIATION INVOLVING AN ADM LINER WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION: THERE ARE SCRATCHES ON THE ARTICULATING SURFACE ON THE ADM INSERT, CONSISTENT WITH IN-VIVO SERVICE AND EXPLANTATION DAMAGE. DIMENSIONAL INSPECTION: THE DEVICE IS DIMENSIONALLY WITHIN SPECIFICATION WITH THE EXCEPTION OF TWO FEATURES. THIS IS MOST LIKELY DUE IMPACTION/EXTRACTION. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED: CT-SCAN SECTION CONFIRMS AN INTRA-PROSTHETIC DISLOCATION OF THE POLY LINER. PRINCIPAL ROOT CAUSE OF FAILURE THUS WAS CUP MALPOSITION LEADING TO IMPINGEMENT AND DISLOCATION. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT CAUSE OF THE EVENT WAS DUE TO CUP MALPOSITION WITH THE INSTABILITY PROBABLY FURTHER AGGRAVATED BY A PROCEDURE-RELATED EFFECT OF CAPSULAR LAXITY EARLY AFTER PREVIOUS REVISION SURGERY. THERE IS NO INDICATION THAT THE REPORTED EVENT WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MDM HIP THAT DISLOCATED. THE POLYETHYLENE LINER AND INNER METAL HEAD THEN BECAME DISSOCIATED WHILE STILL INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MDM HIP THAT DISLOCATED. THE POLYETHYLENE LINER AND INNER METAL HEAD THEN BECAME DISSOCIATED WHILE STILL INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425986 RESTORATION ADM X3 INS 28/54 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36837201

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R