BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 3970187 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02956
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIDENT PSL HA CLUSTER 50MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: INDICATED THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND/OR DEVICES WERE RECEIVED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. DEVICE INFORMATION FOR REFERENCED IN INITIAL EMDR REPORT ¿ACCOLADE TMZF SIZE 3 127; CAT# UNKNOWN LOT# UNKNOWN¿: DESCRIPTION: ACCOLADE PLUS TMZF HIP STEM #3; CAT# 6021-0335; LOT# 44520404.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT 10° X3 INSERT 36MM ID; CAT# 623-10-36E; CAT# MMP0LP; 6.5 CANCELLOUS BONE SCREW 20MM; CAT# 2030-6520-1; LOT# MMM2M2; ACCOLADE TMZF SIZE 3 127; CAT# UNKNOWN LOT# UNKNOWN; DELTA V-40 CERAMIC HEAD 36/0; CAT# 6570-0-136; LOT# 45975301. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL AND SURGEON POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A STRYKER PSL ACETABULAR SHELL ALONG WITH A BONE SCREW, X3 POLY LINER AND CERAMIC 36 MM FEMORAL HEAD WERE EXPLANTED DURING A HIP REVISION. THE SURGEON IMPLANTED A NEW CERAMIC BIOLOX UNIVERSAL FEMORAL HEAD ALONG WITH A UNIVERSAL SLEEVE ONTO THE EXISTING ACCOLADE STEM. SURGEON USED OTHER COMPANY IMPLANTS FOR THE CUP SCREWS AND LINER. THE COMPETITIVE IMPLANTS WERE MANUFACTURED BY DJO.

    Description of Event or Problem · 1

    UPDATE: PER FIRST REQUEST RESPONSE EMAIL DATED 17-JUL-2014, PATIENT WAS REVISED DUE TO HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447164 TRIDENT PSL HA CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MMLPL3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention