BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 28MM +0

    MDR report key: 4202658 · Received October 27, 2014

    Report

    Report Number
    1818910-2014-30702
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    LZO
    PMA / PMN Number
    PK011533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIO ENGINEERING REPORT CONCLUDED THAT THE PRODUCTS WERE RETURNED FOR REVIEW AND HAVE BEEN ANALYSED IN DETAIL BY CERAMTEC (SEE REPORT ATTACHED TO ETQ). THIS INVESTIGATION DID NOT CATEGORICALLY DETERMINE THE ROOT CAUSE BUT CONCLUDED THAT ¿A DISTURBANCE AT THE INTERFACE BETWEEN THE STEM AND BALL HEAD LEADING TO AN INCREASE OF STRESSES, PROBABLY CAUSED THE FRACTURE OF THE CERAMIC BALL HEAD¿. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. NO CORRECTIVE ACTION IS REQUIRED. POST MARKET SURVEILLANCE IS PER (B)(4). A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A REVIEW OF THE MANUFACTURING RECORDS FOR BOTH PRODUCTS IDENTIFIED THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINABLE CAUSE. SHOULD FURTHER INFORMATION BECOME AVAILABLE THEN THE COMPLAINT MAY BE INVESTIGATED FURTHER. THE RETURNED PRODUCTS WILL BE RETAINED IN SECURE STORAGE AREA FOR FUTURE REFERENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    AN SROM STEM THAT WAS REVISED AFTER 5 YEARS WAS DEFORMED AT THE TRUNION AND THE CERAMIC HEAD WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683673 DELTA CER HEAD 11/13 28MM +0 HIP FEMORAL HEAD LZO 9616671 DEPUY (IRELAND) 2558228

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention