BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2923330 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-01387
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 11, 2011
    Report Date
    December 21, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES B5RCA1 AND 2482092. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2511974 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT WAS REVISED TO REPAIR THE FEMORAL STEM, WHICH APPEARED LOOSE. UPDATE: (B)(4) 2012- MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. PART/LOT WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. RECORDS ARE AVAILABLE ON THE L:\DRIVE IF NEEDED FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF STEM. ADDED LAWYER IN ASSOCIATED CONTACT, LAW FIRM, SURGEON, ACCOUNT NAME, MANUFACTURED DATE, EXPIRATION DATE IN IPS, AGE AND UPDATED PATIENT HARM. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30434 PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS, INC. 1818910  2482092

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention