BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3177452 · Received June 19, 2013

    Report

    Report Number
    1818910-2013-19249
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    July 1, 2008
    Report Date
    August 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 ZW9EP1000, Y68GA4000, AND YF9AY4000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1906172 AND 1123470 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    UPDATE: (B)(4) 2013. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF A LOOSE CUP. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : 1906172. DEVICE HISTORY REVIEW: NO RELATED DEVIATIONS OR ANOMALIES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, DISCOMFORT, LIMITED MOBILITY, GRINDING SENSATIONS, AUDIBLE SQUEAKING AND TOXIC COBALT AND CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE.

    Description of Event or Problem · 1

    UPDATE SEP 22, 2017: PFS AND MEDICAL RECORDS RECEIVED. THERE IS NO NEW ALLEGATIONS. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PATIENT WAS ALSO REVISED TO ADDRESS SEVERE SHORTENING. REVISION NOTES REPORTED NO BONY INGROWTH IN THE ACETABULAR COMPONENT. THIS COMPLAINTS WAS UPDATED ON OCT 16, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277665 PINNACLE MTL INS NEUT36IDX54OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 1906172

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention