BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2747408 · Received September 11, 2012

    Report

    Report Number
    2249697-2012-01542
    Event Type
    Injury
    Date Received
    September 11, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 24, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THE REPORT: LRG TAP PRI MOD NCK 0DEG 30 MM, CAT# NLS-30000B, LOT# 38653302; DELTA V-40 CERAMIC HEAD 32/+4, CAT# 6570-0-232, LOT# 722227. IT CANNOT BE DETERMINED WHICH, IF ANY, OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFO HAS BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCING HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CAT# 6570-0-232, LOT# 722227| LRG TAP PRI MOD NCK 0DEG 30MM:| CAT# NLS-30000B, LOT# 38653302| DELTA V-40 CERAMIC HEAD 32/+4: