BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 56MM

    MDR report key: 2151200 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11544
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 1/17/2013 - LITIGATION PAPERS RECEIVED. IN ADDITION TO PAIN AND INSTABILITY, IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM INFLAMMATION, BURSITIS, AND ELEVATED LEVELS OF COBLAT CHROMIUM. (LEFT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Additional Manufacturer Narrative · 1

    ADDED: EVENT/PROBLEM DESCRIPTION, DATE RECEIVED BY MANUFACTURER. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING LITIGATION INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATED: DATE OF BIRTH, WEIGHT, EVENT/PROBLEM DESCRIPTION, IMPLANT DATE, DATE RECEIVED BY MANUFACTURER. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    PATIENT REVISED FOR PAIN AND INSTABILITY.

    Description of Event or Problem · 1

    PATIENT REVISED FOR PAIN AND INSTABILITY. UPDATE - (B)(4) 2013 - LITIGATION PAPERS RECEIVED. IN ADDITION TO PAIN AND INSTABILITY, IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM INFLAMMATION, BURSITIS, AND ELEVATED LEVELS OF COBALT CHROMIUM.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. PATIENT REVISED FOR PAIN AND INSTABILITY. UPDATE 1/17/2013 - LITIGATION PAPERS RECEIVED. IN ADDITION TO PAIN AND INSTABILITY, IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM INFLAMMATION, BURSITIS, AND ELEVATED LEVELS OF COBALT CHROMIUM. UPDATE 4/16/2013 - PFS AND MEDICAL RECORDS RECEIVED. THE CORRECT DOI WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 100 ACET CUP 56MM 87 KWA, LZO KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA CP1FM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention