BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2682737 · Received July 31, 2012

    Report

    Report Number
    2249697-2012-01031
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    November 5, 2018
    Report Date
    December 3, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    Z-2089/2090-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 8DEG 42MM, CAT# NLV-420800Y, LOT# 31618701. TRIDENT PSL HA CLUSTER 58MM, CAT# 542-11-58G, LOT# MJMTYN. TRIDENT 0 DEG INSERT 44MM, CAT# 623-00-44G, LOT# MJN94K. DELTA UN.FEM HD 44MM, CAT# 6519-1-044, LOT# 4518502. UNI ADAPTOR SLEEVE V40 TI, CAT# 6519-T-204, LOT# 34661405. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DR. (B)(6) STATED THAT THE PT. HAD ONSET OF PAIN STARTING (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE MEH STRYKER ORTHOPAEDICS-MAHWAH NA MJHNTE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other