BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM HEAD FEMORAL COCR 32+9

    MDR report key: 4232276 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31289
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    January 27, 2011
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JDG
    PMA / PMN Number
    PK920317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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.

    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.(B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT ISLEGAL. PPD ALLEGES DISLOCATION. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDRREPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED DISLOCATION, NECROTICTISSUE, HEMATOMA, AND ANTERIOR TROCHANTERIC IMPINGEMENT ON THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714069 S-ROM HEAD FEMORAL COCR 32+9 HIP FEMORAL HEAD JDG DEPUY IRELAND ¿ REG. # 9616671 3147001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention