BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 50/44 J

    MDR report key: 2101496 · Received May 17, 2011

    Report

    Report Number
    9613350-2011-00309
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS. THE OP REPORT HAS BEEN REVIEWED. IT DOES NOT STATE ANY PECULIARITY. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION 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 CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION 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 CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 07/03/2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. THE DUROM ACETABULAR COMPONENT PRESENTED MODERATE DARK THIRD BODY DEBRIS COATING THE ARTICULATING SURFACE, CHIPPING OF THE ACETABULAR RIM AROUND THE THIRD BODY MASS ON THE UPPER PORTION AND MIXTURE OF DARK AND LIGHT THIRD BODY MATERIAL AROUND THE EDGES OF THE POROUS COATING. NO SIGNS OF INGROWTH WERE SEEN. A LARGE GASH UNDER THE TAPER ON THE NECK WAS OBSERVED. A SLIGHT DISCOLORATION ON THE TAPER OF THE NECK WAS SEEN, ALONG WITH LIGHT STREAKS POSSIBLY FROM CLEANING. MODERATE AMOUNT OF DEBRIS AND DISCOLORATION ON THE INNER TAPER CAVITY FLOOR AND WALL WERE OBSERVED. THE METASUL LDH LARGE DIAMETER HEAD PRESENTED RANDOM SPLOTCHES OF DARK THIRD BODY MATERIAL ON THE NON-ARTICULATING FACE, VERY LIGHT COATING ON THE ARTICULATING SURFACE THAT RESEMBLES WATER MARKS POSSIBLY FROM CLEANING, HEAVY THIRD BODY MATERIAL ON POROUS COATING AND CIRCUMFERENTIAL FINS AND SCALLOPS COVERED WITH THIRD BODY MATERIAL. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. IT IS ALSO REPORTED THAT POST OP, PATIENT EXPERIENCED PAIN. REVISION STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. ADDITIONALLY IT WAS REPORTED THAT THE PT HAD TO UNDERGO A REVISION SURGERY DUE TO PAIN AND STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2397737

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization