BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ4 HI OFF

    MDR report key: 4483443 · Received February 4, 2015

    Report

    Report Number
    1818910-2015-12581
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    September 11, 2014
    Report Date
    January 7, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE COMPLAINT DATABASE SEARCH IDENTIFIED A PREVIOUS RELATED REPORT AGAINST LOT 3121745. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE REMAINING 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE, DISCOMFORT, AND DIFFICULTY AMBULATING. UPDATE 1/7/2015 -PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE FEMORAL STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS (NO LAB RESULTS PROVIDED). IT SHOULD BE NOTED THAT THE PATIENT WAS IMPLANTED WITH A POLY LINER, NOT METAL LINER. THE COMPLAINT WAS UPDATED ON: 2/4/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81083 SUMMIT POR TAPER SZ4 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. 1818910 D5RD11

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention