BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER INSERT 28ID X 50OD

    MDR report key: 4063451 · Received September 5, 2014

    Report

    Report Number
    1818910-2014-27374
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    MRA
    PMA / PMN Number
    PP070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IMPACTING THE MDR DECISION WAS NOT RECEIVED WITHIN THE THIRTY-DAY DEADLINE DUE TO AN INTERNATIONAL EXTERNAL OVERSIGHT; THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE TOO CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    WE RECEIVED INFORMATION ABOUT A PRODUCT COMPLAINT THAT OCCURRED IN 2011 FROM (B)(6). THE DATA IS: (B)(6), A PATIENT OPERATED IN THIS HOSPITAL IN 2011 SUFFERED A BREAKAGE OF THE CERAMIC INSERT. (B)(4) LOT-2768633 BIOLOX DELTA 28/TAMAÑO 50MM INSERT (BROKEN AND IT WAS NECESSARY TO DO A REVISION IN THIS PATIENT); (B)(4) LOT- 3070820 BIOLOX 28 +5 CERAMIC HEAD (NO PROBLEMA WITH THE HEAD). IT WAS REVISED THE IMPLANT ON (B)(6) 2011 AND WAS IMPLANTED (B)(4) POLI 28/50MM AND BIOLOX 28 +8,5 CERAMIC HEAD. PATIENT IS CURRENTLY IN GOOD HEALTH CONDITION. IT IS REQUESTED FROM THIS HOSPITAL (DEPARTMENT HEAD DR. (B)(6)) A JNJ STATEMENT ON THE CONFORMITY OF THESE IMPLANTS ACCORDING TO APPLICABLE LEGISLATION. THIS PROBABLY IS A LEGAL DEMAND FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546899 DELTA CER INSERT 28ID X 50OD HIP ACETABULAR INSERT/LINER MRA DEPUY IRELAND 9616671 2768633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other