BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3172482 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19007
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    October 9, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. COMPONENTS WERE REMOVED (B)(6) 2013 DUE TO PAIN. ORIGINAL SURGERY (B)(6) 2009. EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST ABNORMAL WEAR. REVIEW OF PROVIDED MEDICAL RECORDS FINDS THE CUP WAS MORE VERTICAL THAN WHAT IS CONSIDERED OPTIMAL. CHEESY MATERIAL AT THE BASE OF THE TRUNNION WAS NOTED, ALTHOUGH THAT THE TRUNNION WAS OTHERWISE SATISFACTORY AND THAT THE INTRAOPERATIVELY THE JOINT WAS SUBLUXING. ONE OTHER REPORT FOUND AGAINST THE (B)(4) ARTICULEZE M HEAD 36MM +1.5 (B)(4). PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER REPORTS WERE FOUND AGAINST THE REMAINING LOT CODES IN SEARCH OF THE COMPLAINTS DATABASES. 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. DEPUY STILL 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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

    ASR REVISION LEFT HIP REASON FOR REVISION: UNKNOWN UPDATE DEC 01, 2017: EMAIL NOTIFICATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. UPDATED COMPLAINANT INFORMATION. ADDED CUP, HEAD, SLEEVE AND STEM PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: DECEMBER 04, 2017. 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

    COMPONENTS WERE REMOVED DUE TO PAIN.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274072 PINNACLE MTL INS NEUT36IDX50OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD. 8010379 2730147

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention