BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM SLEEVE PRX ZTT, 18F-LRG

    MDR report key: 1942066 · Received December 8, 2010

    Report

    Report Number
    1818910-2010-09840
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 8, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(4): ASR DEPUY TOTAL HIP SYSTEM, (B)(4): MODEL# UNK, CATALOG# 9998-00-756, SERIAL# UNK, LOT# 2401969, 2422432,

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED. MEDWATCH REPORT STATES: THE PT WAS ADMITTED TO THE HOSPITAL FOR REMOVAL AND REVISION OF HIS RECALLED ASR DEPUY RIGHT TOTAL HIP THAT HAD BEEN PLACED ON (B)(6) 2007. THE PT HAS HAD PROGRESSIVE PAIN FOR THE PAST YEAR AND A HALF. THE PAIN HAS BECOME DEBILITATING. PREOPERATIVE EVAL SHOWED EVIDENCE OF LOOSENING OF COMPONENTS AND ROTATION OF THE CUP. PREOPERATIVE EVAL FOR INFECTION WAS NEGATIVE. LOT NUMBERS AND CATALOG NUMBERS LISTED ARE FOR THE DEPUY ASR ACETABULAR CUP AND THE UNI FEMORAL IMPLANT. THE PROSTHESIS IN THE POSSESSION OF EXEMPLA CORPORATE RISK MANAGEMENT. ADDITIONAL INFO FROM THE USER FACILITY REPORT: ZTT PROXIMAL SLEEVE LOT# 2238334. (B)(4), S-ROM TOTAL HIP SYSTEM FEMORAL STEM STANDARD LOT# 2395256, (B)(4) AND DEPUY ASR TAPER SLEEVE ADAPTOR LOT# 2368602. (B)(4). THE PROSTHESIS IS IN THE POSSESSION OF EXEMPLA CORPORATE RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM SLEEVE PRX ZTT, 18F-LRG 87LPH LPH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2238334

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention