BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 50MM

    MDR report key: 7670631 · Received July 9, 2018

    Report

    Report Number
    1818910-2018-63996
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    June 13, 2018
    Report Date
    June 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4) INVESTIGATION SUMMARY NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT 7922106 DEVICE HISTORY REVIEW NO ANOMALIES 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

    FRACTURE OF THE LINER AND DISLOCATION OF THE LINER. THE MATERIALS OF THE TOTAL HIP ARTHROPLASTY WERE STABLE. - THE PATIENT WAS SUBJECTED TO TOTAL HIP REPLACEMENT IN (B)(6) 2015. ON (B)(6) 2018 REPORTED STRANGE NOISE - CREAKING IN TOTAL ARTHROPLASTY. IN THE RADIOLOGY TEST, A HEAD SHIFTING WAS FOUND DUE TO POLYETHYLENE DAMAGE. IT WAS SURGICALLY OPERATED ON (B)(6) 2018 AND IT WAS FOUND THAT THE POLYETHYLENE LIFT WAS BROKEN AND THE MATERIAL WAS COMPLETELY UNBLOCKED. NEW POLYETHYLENE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513702 PINNACLE SECTOR II CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 7922106

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention