BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN-A SECTOR ACET CUP 50MM

    MDR report key: 7822386 · Received August 28, 2018

    Report

    Report Number
    1818910-2018-67871
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    December 12, 2017
    Report Date
    August 6, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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. MEDICAL DEVICES: SROM 9/10 20X15X145 42 900541210; S-ROM*SLEEVE PRX ZTT, 20B-LRG 521405; 9/10 ULTAMET 36MM HEADS -3 962710000; APEX HOLE ELIM POSITIVE STOP 124603000; PINNACLE-A SCREW 6.5X15 556070J.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011. THE PATIENT VISITED TO THE HOSPITAL DUE TO DISLOCATION ON (B)(6) 2017, AND THE HEMATOMA WAS FOUND VIA MRI ON (B)(6) 2017. THEN, THE BLACKISH BROWN SCAR LIKE TISSUE WHICH SEEMS TO BE A PSEUDOTUMOR WAS REMOVED. ALSO, THE SURGEON FOUND THE LINEAR FRICTION MARK ON THE STEM NECK AND A LARGE AMOUNT OF METAL ABRASION POWDER INSIDE THE HEAD TAPER, SO THAT THE SURGEON DECIDED TO PERFORM THE REVISION SURGERY. THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2017. 900541210 (STEM, LOT# WAS UNKNOWN), 521405 (SLEEVE, LOT# WAS UNKNOWN), 962710000 (HEAD, LOT# WAS UNKNOWN), 121887350 (METAL INSERT, LOT# WAS UNKNOWN), 556070J (SCREW, LOT# WAS UNKNOWN), 121782050 (CUP, LOT# WAS UNKNOWN), 124603000 (HOLE ELIMINATOR, LOT# WAS UNKNOWN) WERE EXPLANTED AND IMPLANTED POROCOAT 52 (P/N: 121782052, LOT# WAS UNKNOWN), C-STEM AMT LONG #3 HO (P/N AND LOT# WERE UNKNOWN) TO THE PATIENT¿S BODY. HOWEVER, IT CAUSED EXTENSIVE BONE DEFECT UNDER THE TRIANGLE WHEN REMOVING THE SLEEVE ALTHOUGH AN ADHESIVE BONE WAS DELIBERATELY PEELED OFF. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2011; DOR: (B)(6) 2017; UNKOWN AFFECTED HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664583 PINN-A SECTOR ACET CUP 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention