BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 28MM/-3

    MDR report key: 3120741 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01725
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT WAS A RESTORATION ADM X3 INSERT 28/58, CAT # 1236-2-858, LOT # 37857301. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A C-TAPER COCR LFIT HEAD 28MM/-3 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    PATIENT SLIPPED 7 DAYS POST OP. THE PATIENT CAME TO DOCTOR'S OFFICE COMPLAINING OF PAIN, THE PATIENT WAS ADVISED REVISION SURGERY NEEDED TO BE DONE, THE PATIENT HAD A TORN ABDUCTOR TENDON,WHICH WAS REPAIRED. WHILE DOCTOR WAS IN SURGERY OPTED TO CHANGE POLY AND HEAD.

    Description of Event or Problem · 1

    PATIENT SLIPPED 7 DAYS POST OP. THE PATIENT CAME TO DOCTOR'S OFFICE COMPLAINING OF PAIN, THE PATIENT WAS ADVISED REVISION SURGERY NEEDED TO BE DONE, THE PATIENT HAD A TORN ABDUCTOR TENDON,WHICH WAS REPAIRED. WHILE DOCTOR WAS IN SURGERY OPTED TO CHANGE POLY AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222602 C-TAPER COCR LFIT HEAD 28MM/-3 IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH MLEW1A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other