BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX60OD

    MDR report key: 2232680 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15614
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 31, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD. PER PROCEDURE, THIS DEVICE IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT/LOT COMBINATIONS HAVE BEEN IDENTIFIED. NO PRODUCTS HAVE BEEN RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THIS MATTER IS IN LITIGATION. FOLLOW-UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. 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

    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

    (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

    (B)(4).

    Description of Event or Problem · 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 PT¿S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN BOTH HIS RIGHT AND 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 PT¿S CHRONIC PAIN AND DISCOMFORT AND OTHER SYMPTOMS, PT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT.

    Description of Event or Problem · 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 BOTH HIS RIGHT 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) 2009 - DOR: NONE REPORTED (RIGHT SIDE). (B)(6). UPDATE - DER RECEIVED FROM SALES REP INDICATES THAT THE PATIENT WAS REVISED (B)(6) 2011 TO ADDRESS THE STEM BEING LOOSE AND UNDERSIZED.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED LOOSE STEM THAT HAD SUBSIDED AND RIGHT LEG WAS SHORTER. THERE WERE NO LAB RESULTS PROVIDED FOR THE ALLEGED HIGH METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    THERE WERE NO NEW ALLEGATIONS. ADDED PATIENT'S AGE, ACCOUNT NAME, FACILITY NAME, LAWYER, EXPIRATION DATE OF HEAD AND LINER AND UPDATED PATIENT'S INITIALS. CORRECTED THE IMPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX60OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 NA 2773026

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention