BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2757054 · Received September 20, 2012

    Report

    Report Number
    2249697-2012-01611
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    August 31, 2012
    Report Date
    August 31, 2012
    Manufacturer
    STRKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP MOD NCK 8DEG 30MM, CAT# NLV-300800G, LOT# 32987601; DELTA V40 HEAD 36MM+0, CAT# UNK, LOT# UNK; TRIDENT 10 DEG X3 INSERT 36MM ID, CAT# 623-10-36F, LOT# MJRNLL; PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM, CAT# 502-03-60F, LOT# MJPJ96. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTED TOTAL HIP. ALL IMPLANTS REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT JDI STRKER ORTHOPAEDICS MAHWAH NA MJDNP3

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention