BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM HEAD FEMORAL COCR 28+3

    MDR report key: 1106546 · Received August 8, 2008

    Report

    Report Number
    1818910-2008-03221
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDG
    PMA / PMN Number
    K920317
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. COM-012950 HAS BEEN RE-OPENED UNDER PC-000310957 DUE TO THE RECEIPT OF PFS AND MEDICAL RECORDS. THERE IS NO NEW INFORMATION. ADDED LAWYER, LAW FIRM AND PATIENT INITIALS. UPDATED PRODUCT DETAILS. DOI: (B)(6) 2006; DOR: JUL 18, 2008; RIGHT HIP. REASON FOR ORIGINAL COMPLAINT: PATIENT WAS REVISED TO ADDRESS DISLOCATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE INVESTIGATION PERFORMED OF COM-012950. THE COM INVESTIGATION IS STILL VALID; A SUMMARY CAN BE FOUND IN THE PC-ATTACHMENTS.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM HEAD FEMORAL COCR 28+3 87JDG JDG DEPUY ORTHOPAEDICS INC US AN 1927036

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention