BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2232243 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15930
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    December 31, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    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

    LITIGATION PAPERS ALLEGE THE FOLLOWING: AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. DUE TO PATIENTS CHRONIC PAIN AND DISCOMFORT AND OTHER SYMPTOMS, PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT SIDE). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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. 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

    (B)(4). 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.(B)(4).

    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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE FOLLOWING: AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. DUE TO PT'S CHRONIC PAIND AND DISCOMFORT AND OTHER SYMPTOMS, PT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT.

    Description of Event or Problem · 1

    UPDATE 12/31/2014- PFS AND MEDICAL RECORDS RECEIVED. A DOR WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN. THE STEM IS BEING ADDED FOR THE ALLEGED HIGH METAL IONS (NO LABS PROVIDED). THE UNKNOWN HIP IS BEING CHANGED TO AN ACETABULAR LINER. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    THERE IS NO NEW ALLEGATION REPORTED. ADDED AGE, ACCOUNT NAME, FACILITY NAME AND ADDITIONAL CONTACTS. CORRECTED HEAD AND LINER EXPIRATION DATE, STEM PROCODE AS WELL AS PATIENT IDENTIFIER. DOI: (B)(6) 2008; DOR: (B)(6) 2012; (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 2578629

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention