BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2252512 · Received September 17, 2011

    Report

    Report Number
    1818910-2011-18188
    Event Type
    Injury
    Date Received
    September 17, 2011
    Date of Event
    December 31, 2014
    Report Date
    August 25, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS AGAINST THE LOT CODE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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.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

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. 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

    PATIENT WAS REVISED BECAUSE SHE DISLOCATED IN 2009 AND HAS HAD PAIN EVER SINCE.

    Description of Event or Problem · 1

    UPDATE 12/31/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE CONFIRMED DISLOCATION. THE PRIMARY OPERATION ON (B)(6) 2008 REMOVED A LOOSE STEM, AT THIS TIME THE MANUFACTURER OF THE STEM IS UNKNOWN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    PPF ALLEGES ELEVATED METAL IONS. ADDED LAW FIRM, ASSOCIATED CONTACT, ACCOUNT NAME, PRODUCT DETAILS IN ALL IPS. ADDED STEM DUE TO ALLEGED METAL IONS. DOI: (B)(6) 2008 DOR: AUG 25, 2011 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2452973

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention