BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16F-SML

    MDR report key: 3150504 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18328
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    September 19, 2012
    Report Date
    May 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2797864, 2675441, AND 2474920. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2587500 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT- PATIENT WAS REVISED TO ADDRESS CLICKING AND CATCHING, AND A SMALL AMOUNT OF METALLOSIS. DOI (B)(6) 2009 - DOR (B)(6) 2012 (LEFT HIP). **UPDATE** (B)(4) 2013- LITIGATION PAPERS RECEIVED. IN ADDITION TO NOISE AND METALLOSIS, IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LOOSENING, INSTABILITY, AND LIMITED MOBILITY. DUE TO LOOSENING, AN UNKNOWN DEVICE WAS ADDED. THE DOI WAS ALSO PROVIDED, (B)(6) 2009. **UPDATE** (B)(4) 2013 - REPORT ((B)(4)) SUBMITTED BY THE PATIENT PROVIDED PART AND LOT INFORMATION. **UPDATE** (B)(4) 2013- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. THE STEM WAS IDENTIFIED AS SROM, THEREFORE, WE ADDED THE SLEEVE. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249931 S-ROM*SLEEVE PRX ZTT, 16F-SML SLEEVE LPH DEPUY ORTHOPAEDICS INC US 2474920

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention