BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 40 +5

    MDR report key: 2239206 · Received September 8, 2011

    Report

    Report Number
    1818910-2011-17642
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS EVENT AS DETERMINED THE DEPUY LEGAL TEAM, HAVE BEEN SENT FOR EXTERNAL EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A REVIEW OF PROVIDED MEDICAL RECORDS AND PATIENTS X-RAYS HAVE BEEN EXAMINED BUT DID NOT IDENTIFY A ROOT CAUSE OR PRODUCT CONTRIBUTION. THE COMPLAINT WILL BE REOPENED UPON RECEIPT OF A REPORT FROM THE EXTERNAL EVALUATING FACILITY. 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). PREVIOUS EXAMINATION OF THE RETURNED PRODUCT FINDS NOTHING OUTWARD TO SUSPECT PRODUCT CONTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED LOT CODE 2865971 OR 3028917. 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 AT THIS TIME. 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). ADDED: PATIENT/DEVICE.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN AND EXCESS FLUID IN THE JOINT. UPDATE:(B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES TISSUE REACTION SECONDARY TO METAL ION WEAR. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN AND EXCESS FLUID IN THE JOINT.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN AND EXCESS FLUID IN THE JOINT. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES TISSUE REACTION SECONDARY TO METAL ION WEAR. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE REC¿D (B)(6) 2013 ¿ PFS AND MEDICAL RECORDS RECEIVED. REVISION OPERATIVE CONFIRMED REASON FOR REVISION, "ADVERSE LOCAL TISSUE REACTION SECONDARY TO METAL ION WEAR." THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. RECORDS ARE ATTACHED FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES METALLOSIS. ADDED LAWYER, SURGEON, FACILITY NAME AND REVISION HOSPITAL. UPDATED PATIENT'S NAME. CORRECTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPHERE M SPEC 12/14 40 +5 HIP HEAD BALL KWA DEPUY ORTHOPAEDICS, INC. 1818910 2865971

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R