BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 2910958 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00808
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    January 5, 2010
    Report Date
    December 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES 2751399 AND C67BM1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST BOTH LOT CODES 2775119 AND C1TB51 SINCE THEIR 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

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED SERIOUS PHYSICAL INJURY, HARM AND DAMAGES. **UPDATE** 12/17/2012- MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATED THAT THE PATIENT WAS REVISED DUE PAIN, METALLOSIS, AND IMPINGEMENT ON THE BACK OF THE CUP. THE STEM AND CUP WERE ADDED TO THE COMPLAINT. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17962 PINNACLE SECTOR II CUP 52MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US C67BM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention