BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE CUP

    MDR report key: 2213186 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15321
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    July 13, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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

    CORRECTED: DATE OF IMPLANT. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). TERRITORY 230 REPORTS: PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED WHICH INDICATES THAT THE PATIENT HAD PINNACLE DEVICES. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. TWO OF THE SCREWS HOLDING THE CUP IN PLACE WERE LOOSE. ADDITIONALLY IT IS NOTED THAT THE CUP SHOWED NO INGROWTH. DOI: UNK; DOR: (B)(6) 2011 (RIGHT HIP). 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 CODE REQUIRED WERE UNAVAILABLE. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED WHICH INDICATES THAT THE PT HAD PINNACLE DEVICES. MEDICAL RECORDS INDICATE THAT THE PT WAS REVISED TO ADDRESS PAIN. TWO OF THE SCREWS HOLDING THE CUP IN PLACE WERE LOOSE. ADDITIONALLY, IT IS NOTED THAT THE CUP SHOWED NO INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE CUP TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention