BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +6

    MDR report key: 3980912 · Received August 5, 2014

    Report

    Report Number
    1818910-2014-25027
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF PROVIDED PATIENT X-RAYS DID NOT PROVIDE ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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. IT WAS INITIALLY REPORTED THE PATIENT FELL AND FRACTURED THEIR RIGHT GREATER TROCHANTER. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. MONITOR THROUGH TRENDING VIA (B)(4).DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    PROCEDURE: REVISION RIGHT TOTAL HIP ARTHROPLASTY. PATIENT HAD MECHANICAL FALL AND FRACTURED RIGHT GREATER TROCHANTER. ON X-RAY PATIENT DISPLAYS PRE-EXISTING OSTEOLYSIS. DATE OF PRIMARY PROCEDURE (B)(6) 2003. PRIMARY IMPLANTS ARE: 52MM PINNACLE 100 CUP HA, 36MM METAL LINER, SROM STEM 18X13X160 42 STANDARD NECK, 18D LARGE HA SLEEVE AND 36MM +6 HEAD. NO REFERENCE NUMBERS AVAILABLE. X RAYS TO FOLLOW. PHOTO OF X RAY AVAILABLE. PATIENT DETAILS: INITIALS (B)(6)., DOB (B)(6) 1968, AGE (B)(6), GENDER MALE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457075 S-ROM M HEAD 36MM +6 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 YMK79

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention