BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER MMC CUP 52MM/.44MM CODE J

    MDR report key: 4751510 · Received May 1, 2015

    Report

    Report Number
    9613350-2015-00507
    Event Type
    Other
    Date Received
    May 1, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION OPERATION REPORT DESCRIBES A LARGE PSEUDOCYST FILLED WITH SEROSANGUINEOUS FLUID, GOOD BONE QUALITY, BUT NO SIGNIFICANT BONY ONGROWTH ONTO THE ACETABULAR COMPONENT. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFEMA: INCREASED WEAR - DUE TO CLEARANCE TOO SMALL, RIM LOADING. INCREASED WEAR - DUE TO CLEARANCE TOO LARGE. INCREASED LEVEL OF IONS - DUE TO CHEMICAL/CREVICE/CORROSION. INCREASED NUMBER OF WEAR PARTICLES - DUE TO CHEMICAL CORROSION. REDUCED ROM: INCREASED WEAR - DUE TO COMPONENT MALPOSITIONING. INCREASED WEAR - DUE TO COMPONENT DAMAGED DURING OPERATION - SCRATCHES ON ARTICULATION SURFACE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THIS IS A BILATERAL CLAIM: RIGHT COMPLAINT IS REPORTED UNDER (B)(4) (9613350-2015-00509).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2015. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THIS IS A BILATERAL PATIENT THE RIGHT SIDE WAS REPORTED UNDER (B)(4). ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOUCMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION 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 NOTIFICATION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE RIGHT SIDE (EXACT DATE NOT REPORTED). CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO UNKNOWN REASONS. THIS IS A BILATERAL CLAIM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT THR FOR HEAD, NECK AND CUP DUE TO METALLOSIS AFTER 4 YEARS 6 MONTHS IN VIVO. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A TREND WAS IDENTIFIED (3 COMPONENTS WITHIN 3 MONTHS FOR THE MMC CUP REF (B)(4) WITH SIMILAR EVENT) AND A TREND INVESTIGATION HAS BEEN INITIATED. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. THE INSPECTION PLAN SAP STATES THAT THE SURFACE OF CALOTTE IS 100 PERCENT INSPECTED BY ATTRIBUTES WITH GAUGE.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A ZIMMER MMC CUP ON THE LEFT SIDE ON (B)(6) 2010. THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289490 ZIMMER MMC CUP 52MM/.44MM CODE J ZIMMER MMC CUP KWA ZIMMER GMBH 2521452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other