BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR HA ACET CUP 54MM

    MDR report key: 4190236 · Received October 21, 2014

    Report

    Report Number
    1818910-2014-30326
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    March 7, 2013
    Report Date
    October 14, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LPH
    PMA / PMN Number
    PK031495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO ADDITIONAL INVESTIGATIVE INPUTS OR EVENT INFORMATION WAS PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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

    INFORMATION RECEIVED FROM (B)(6). ONLY A MANUFACTURING DATE REQUEST RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANT REVISION. REVISION DATE CONFIRMED. REASON FOR REVISION NOT KNOWN. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. 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

    INFORMATION RECEIVED FROM (B)(6) ONLY A MANUFACTURING DATE REQUEST RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANT REVISION. REVISION DATE CONFIRMED. REASON FOR REVISION NOT KNOWN. UPDATE (B)(4)- CONFIRMATION OF FORMAL CLAIM RECEIVED FROM (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS METAL ON METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668481 PINN SECTOR HA ACET CUP 54MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. 1818910  DE1B91000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other