BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 50MM

    MDR report key: 3191458 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-02232
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    August 23, 2010
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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 ANY 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THE FOLLOWING: ON (B)(6) 2009, PATIENT HAD A PINNACLE HIP IMPLANTED IN HER RIGHT SIDE. ON (B)(6) 2010, PATIENT HAD A PINNACLE HIP IMPLANTED IN HER LEFT SIDE. SHORTLY AFTER THE (B)(6) 2010 SURGERY, PATIENT BEGAN EXPERIENCING PAIN IN HER LEFT HIP AND GROIN. THIS PAIN WENT ON FOR MONTHS AND INCLUDED SWELLING AND DEFORMITY OF THE LEFT HIP. EVENTUALLY, PATIENTS LEFT HIP IMPLANT FAILED WHICH RESULTED IN A PELVIC FRACTURE. ON (B)(6) 2010, PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE METAL-ON-METAL COMPONENTS THAT HAD FAILED. DOI: (B)(6) 2009 - DOR: UNKNOWN IF REVISED (RIGHT SIDE). DOI: (B)(6) 2010 - DOR: (B)(6) 2010 (LEFT SIDE). PATIENT IS A (B)(6). **UPDATE** (B)(4) 2012 - PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATED THAT THE LEFT HIP WAS REVISED DUE TO ACETABULUM FRACTURE DUE TO A FALL AND PAIN. THE ACETABULUM CUP WAS ADDED TO COMPLAINT. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    PATIENT NAME WAS UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291272 PINNACLE 300 ACET CUP 50MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US D2BJX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention