BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 42MM

    MDR report key: 2931268 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00351
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    July 2, 2012
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). NO DEVICE FAILURE MODES OR PATIENT HARMS WERE IDENTIFIED IN THE REPORTED EVENT. NCR WAS INITIATED BECAUSE THE OCCURRENCE RATE FOR ADVERSE LOCAL TISSUE REACTION (ALTR) SPECIFIED IN THE RISK MANAGEMENT FILES FOR THE REJUVENATE MODULAR HIP SYSTEM WAS EXCEEDED. GIVEN THE POTENTIAL RISK OF FRETTING AND CORROSION WITH THESE DEVICES, VOLUNTARY PRODUCT RECALL RA (B)(4) WAS ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: LABS TAKEN ON 7/2/2012 INDICATE SLIGHTLY ELEVATED COBALT (2.3 NG/ML) AND CHROMIUM (0.6 NG/ML) ION LEVELS. A CHART NOTE DATED (B)(6) 2012 INDICATED "PATIENT ASYMPTOMATIC" AND MRI "NEGATIVE FOR ANY ADVERSE LOCAL TISSUE REACTION". THE PATIENT WILL RETURN IN (B)(6) 2013 FOR A 2-YEAR FOLLOW-UP VISIT. PRE AND POSTOPERATIVE RADIOGRAPHS ARE ON FILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: LABS TAKEN ON (B)(6) 2012 INDICATE SLIGHTLY ELEVATED COBALT (2.3 NG/ML) AND CHROMIUM (0.6 NG/ML) ION LEVELS. A CHART NOTE DATED (B)(6) 2012 INDICATED "PATIENT ASYMPTOMATIC" AND MRI "NEGATIVE FOR ANY ADVERSE LOCAL TISSUE REACTION". THE PATIENT WILL RETURN IN (B)(6) 2013 FOR A 2-YEAR FOLLOW-UP VISIT. PRE AND POSTOPERATIVE RADIOGRAPHS ARE ON FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37342 LRG TAP PRI MOD NCK 0DEG 42MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 32301601

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other