BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOLOX DELTA CER HEAD 36 12/14

    MDR report key: 4834266 · Received June 9, 2015

    Report

    Report Number
    9613350-2015-00650
    Event Type
    Other
    Date Received
    June 9, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    EML
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 08/04/2015. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED DEVICE(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) WAS UNKNOWN. PATIENT FACTORS THAT MIGHT AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY WERE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL WAS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT WAS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. HOWEVER, THE POSSIBLE CAUSES ARE COVERED IN THE DFMEA OF THE REPORTED DEVICE. 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).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW 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 FOR THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA CER HEAD 36 12/14 ON AN UNKNOWN DATE. IT IS NOW REPORTED THAT THE PATIENT IS EXPERIENCING UNKNOWN DISCOMFORTS. NO FURTHER DETAILS ARE KNOWN AT THAT STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370669 BIOLOX DELTA CER HEAD 36 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD EML ZIMMER GMBH 2552369

    Patients

    Seq Age Sex Outcome Treatment
    1 Other