BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° CROSSFIRE INSERT 32 MM ID

    MDR report key: 3970742 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02963
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 3, 2005
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K983502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 52MM; CAT# 542-11-52E; LOT# 27376905; MERIDIAN TMZF HIP STEM #2/12MM; CAT# 6265-1-005; LOT# 10009603; 6.5 CANCELLOUS BONE SCREW 30MM; CAT# 2030-6530-1; LOT# 28058306; 6.5 CANCELLOUS BONE SCREW 40MM; CAT# 2030-6540-1; LOT# 27649001. 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 REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE CORRECTED. AN EVENT REGARDING REVISION SURGERY INVOLVING A TRIDENT 10° CROSSFIRE INSERT 32 MM ID WAS REPORTED. 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. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW INDICATED THAT. ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND/OR DEVICE WERE MADE AVAILABLE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS SCHEDULED FOR REVISION SURGERY. UPDATE (B)(6) 2014: PATIENT REPORTED THAT SURGEON ADVISED THE LINER NEEDS TO BE REPLACED DURING REVISION SURGERY. PATIENT IS SCHEDULED FOR RIGHT HIP REVISION SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS SCHEDULED FOR REVISION SURGERY. UPDATE (B)(6) 2014: PATIENT REPORTED THAT SURGEON ADVISED THE LINER NEEDS TO BE REPLACED DURING REVISION SURGERY. PATIENT IS SCHEDULED FOR RIGHT HIP REVISION SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446648 TRIDENT 10° CROSSFIRE INSERT 32 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 1YSLTF

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other