BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 2881669 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-84000
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    June 1, 2009
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE 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. REVIEW OF PROVIDED MEDICAL RECORDS AND X-RAYS WAS NOT ABLE TO VERIFY ANY DEPUY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ON NOVEMBER 28, 2007 A RIGHT HIP SURGERY AT THE (B)(4) HOSPITAL, DURING WHICH SHE WAS IMPLANTED WITH A PINNACLE ACETABULAR CUP, A BIOLOX ¿ DELTA CERAMAX CERAMIC INSERT, A CORAIL FEMORAL STEM AND A BIOLOX ¿ DELTA ARTICULEEZE CERAMIC FEMORAL HEAD . -ON MAY 31, 2009 THE PATIENT WAS HOSPITALISED AT THE SAME HOSPITAL WITH DIAGNOSIS OF ¿RUPTURE OF THE ACETABULAR CERAMIC INSERT¿ AND, ON JUNE 1, 2009, UNDERWENT A REVISION SURGERY DURING WHICH THE AFORESAID PROSTHESIS WAS REPLACED; -ACCORDING TO THE PATIENT¿S LAWYER, THE AFORESAID RUPTURE WOULD BE IMPUTABLE TO THE ¿BAD QUALITY¿ AND/OR ¿DEFECTIVENESS¿ OF THE PROSTHESIS. AUG 20 2013 - UPDATE - TRANSLATION OF MEDICAL DOCUMENTS RECEIVED, AND ATTACHED. COMPLAINT BEING REOPENED. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. PRODUCT CODE 136536320, WORK ORDER (B)(4) WAS MANUFACTURED ON 06 SEPTEMBER 2007. (B)(4). DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED THROUGH DEPUY (B)(4) INVESTIGATION. RETURNED PRODUCT WILL HAVE A PRODUCT ANALYSIS CONDUCTED BY THE SUPPLIER. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALISED WITH DIAGNOSIS OF "RUPTURE OF THE ACETABULAR CERAMIC INSERT" AND UNDERWENT A REVISION SURGERY DURING WHICH THE AFORESAID PROSTHESIS WAS REPLACED;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 36MM +5 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 2460831

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention