BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    MDR report key: 2852369 · Received November 27, 2012

    Report

    Report Number
    9613350-2012-01100
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN (B)(4) 2008. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: CPT STEM WITH LARGE DIAMETER DUROM METAL HEAD WITH A DUROM ACETABULAR COMPONENT WAS IMPLANTED IN 2006 AND THE PT HAS BEEN UNSATISFIED FROM AN EARLY STAGE. FOLLOWING VARIOUS EXPLORATORY PROCEDURES TO ASSESS THE PROBLEM, THE DECISIONS WAS FINALLY MADE TO REVISE. UPON EXPLANTATION, THE STEM SHOWED CONSIDERABLE SIGNS OF TRUNNION WEAR AND ALSO SHOWED SIGNS OF CORROSION AROUND THE MID-SECTION. THE FEMALE TAPER OF THE HEAD WAS WORN, BUT THE ARTICULAR SURFACE OF THE HEAD AND CUP WERE PRISTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 58/52 CODE R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2311491-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R