BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3122592 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-17451
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 13, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR PRODUCT 136553000 AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. **UPDATE** (B)(4) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED ON (B)(4) 2013 TO ADDRESS LATERAL HIP PAIN. PSEUDOTUMOR HAD DEVELOPED. THE LOT NUMBER WAS PROVIDED FOR THE HEAD. THE MDR DECISION FOR THE HEAD AND LINER WILL BE CHANGED FROM MDR-NO TO MDR-YES BASED ON THE PROBLEM OF PSEUDOTUMOR, WHICH WOULD CAUSE PAIN. THE HEAD ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THIS PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED BUT NO ADDITIONAL INFORMATION WAS OBTAINED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED ON BEHALF OF THE PATIENT THAT SHE IS EXPERIENCING EXTREME PAIN AND SENSITIVITY, BUT HAS NOT BEEN REVISED. **UPDATE** (B)(4) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS LATERAL HIP PAIN. PSEUDOTUMOR HAD DEVELOPED. THE LOT NUMBER WAS PROVIDED FOR THE HEAD. THE MDR DECISION FOR THE HEAD AND LINER WILL BE CHANGED FROM MDR-NO TO MDR-YES BASED ON THE PROBLEM OF PSEUDOTUMOR, WHICH WOULD CAUSE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223717 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA 8010379 DEPUY INTL., LTD. 2678119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention