BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURASUL COCR HEAD 38/ 0 'M' 12/14

    MDR report key: 2901319 · Received January 4, 2013

    Report

    Report Number
    9613350-2013-01221
    Event Type
    Other
    Date Received
    January 4, 2013
    Date of Event
    October 2, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS THE PT HAS NOT BEEN REVISED TO DATE. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, AS THE PT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION AND ZIMMER (B)(4) WILL CLOSE THIS CASE. (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF AN ORTHOPEDIC HIP MFG BY SULZER ORTHOPEDICS, INC. (RENAMED CENTERPULSE ORTHOPEDICS, INC. THEN PURCHASED BY ZIMMER HOLDINGS). IT WAS REPORTED BY THE PT'S COUNSEL THAT THE PT RECEIVED AN IMPLANT ON (B)(6) 2001 AND EXPERIENCED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5190 DURASUL COCR HEAD 38/ 0 'M' 12/14 INTER-DURASUL ACETABULAR INSERTS/COCR KWA ZIMMER GMBH 1430748

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other