BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 54MM

    MDR report key: 3914524 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22703
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK071784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. 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

    (B)(4).NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DIFFICULTY AMBULATING. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT ACTUALLY HAD A POLY LINER IMPLANTED. LITIGATION ALLEGED PAIN AND DIFFICULTY WALKING, SO ALL IMPLANTS ARE NOW BEING REPORTED AS NONE OF THEM CAN BE EXCLUDED AT THE CAUSE OF THE PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389554 PINN SECTOR W/GRIPTION 54MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US 312600

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other