BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 2093847 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08343
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    August 2, 2010
    Report Date
    February 12, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE STILL NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS FOR ALL PRODUCTS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    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). THE DEVICES ASSOCIATED WITH THIS REPORT WERE STILL NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS ANDSTERILIZATION CERTIFICATIONS FOR ALL PRODUCTS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS ORANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. THE INVESTIGATION COULD NOTDRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE PROVIDED INFORMATION. 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

    UPDATE REC'D 3/30/2013- PPD AND MEDICAL RECORDS RECEIVED. STICKER SHEETS FROM (B)(6) 2010 AND MEDICAL RECORDS FROM (B)(6) 2010 INDICATED SPACERS WERE PLACED ON (B)(6) 2010 FOR INFECTION AND THE PATIENT WAS REIMPLANTED ON (B)(6) 2010 WITH NON DEPUY PRODUCTS. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    (B)(4).

    Description of Event or Problem · 1

    PPF ALLEGES FRACTURE (BONE), METAL WEAR AND METALLOSIS.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM WHICH WAS CAUSED BY THE INFECTION. UPDATE: (B)(6) 2011 - LITIGATION PAPERS RECEIVED. LITIGATION PAPERS ALLEGE: PATIENT WAS CAUSED SEVERE PAIN, HIS ABILITY TO WALK WAS INHIBITED, AND A REVISION SURGERY WAS REQUIRED; PATIENT CONTINUED TO SUFFER FROM SEVERE PAIN AND DIFFICULTY WALKING, AND HAD A SECOND REVISION SURGERY; PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, SEVERE PAIN, SUFFERING, AND INCONVENIENCE, MEDICAL EXPENSES, AND THE LIKELIHOOD OF FUTURE MEDICAL EXPENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX56OD 87KWA KWA DEPUY ORTHOPAEDICS INC US NA 2888064

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention NA.