BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER MMC CUP 50MM/42MM CODE H

    MDR report key: 4742827 · Received April 30, 2015

    Report

    Report Number
    9613350-2015-00486
    Event Type
    Other
    Date Received
    April 30, 2015
    Date of Event
    November 1, 2014
    Report Date
    April 16, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW; NO DEVICES WERE RECEIVED AS THE PATIENT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO TREND IDENTIFIED. THE PRODUCT COMBINATION USED IS APPROVED BY ZIMMER. NEITHER X-RAYS, OPERATIVE NOTES, NOR OFFICE VISIT NOTES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH IS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. POSSIBLE CAUSES FOR THE REPORTED EVENT - ASEPTIC LOOSENING - ACCORDING TO DFMEA: DUE TO DEFORMATION OF THE CUP DUE TO BAD BONE CONDITION (E.G. SCLEROSIS); DUE TO FAILURE OF CONNECTION BETWEEN COATING (TI-VPS) AND SUBSTRATE (COCR); DUE TO FAILURE OF CONNECTION BETWEEN COATING (HA) AND SUBSTRATE (TI-VPS); DUE TO SURFACE DOES NOT ALLOW BONE ON-GROWTH; DUE TO BONE GROWS ONTO HA LAYER AND SUBSEQUENTLY THE HA LAYER FAILS; DUE TO INADEQUATE PLANNING AND SURGICAL TECHNIQUE, USE OF INSTRUMENTS: DUE TO INCOMPLETE SEATING OF THE CUP AND NOT RECOGNIZED BY THE SURGEON; DUE TO CUP IMPLANTED IN WRONG ORIENTATION (MALPOSITIONING); DUE TO HA LAYER BECOMES LOOSE AND PREVENTS STABLE FIXATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A MMC CUP 50MM/42MM CODE HON (B)(6) 2010 ON THE RIGHT SIDE AND EXPERIENCED LOOSENING IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284929 ZIMMER MMC CUP 50MM/42MM CODE H ZIMMER MMC CUP KWA ZIMMER GMBH NA 2520767

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other