BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM

    MDR report key: 2946359 · Received February 6, 2013

    Report

    Report Number
    0002249697-2013-00579
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    3/31/2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT TOTAL HIP AND DOCTOR DID A BONE SCAN NOTHING LIT UP. SURGEON DECIDED TO REVISE. NERVE WAS ENCAPSULATED, POLY SWAP, HEAD SWAP TO SEE IF HE COULD FIND ANYTHING. TOOK HEAD AND POLY OUT, PUT TRIAL IN, DID RANGE OF MOTION TEST, DISCOVERED IMPINGEMENT WHICH MAY BE THE REASON FOR PAIN. THEN TOOK OUT THE CUP. PUT NEW CUP IN WITH STRYKER MDM LINER. NO FURTHER INFORMATION AS PER HOSPITAL AND DOCTOR POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT TOTAL HIP AND DOCTOR DID A BONE SCAN NOTHING LIT UP. SURGEON DECIDED TO REVISE. NERVE WAS ENCAPSULATED, POLY SWAP, HEAD SWAP TO SEE IF HE COULD FIND ANYTHING. TOOK HEAD AND POLY OUT, PUT TRIAL IN, DID RANGE OF MOTION TEST, DISCOVERED IMPINGEMENT WHICH MAY BE THE REASON FOR PAIN. THEN TOOK OUT THE CUP. PUT NEW CUP IN WITH STRYKER MDM LINER. NO FURTHER INFORMATION AS PER HOSPITAL AND DOCTOR POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51243 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJMTX3

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention