BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 11337584 · Received February 17, 2021

    Report

    Report Number
    1818910-2021-03135
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 2, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: FOR ALLEGATIONS OF PAIN A DEVICE MANUFACTURING (MRE) REVIEW WILL NOT BE PERFORMED EVEN WHEN PRODUCT/LOT INFORMATION IS KNOWN. PER (B)(4), REVIEW OF THE DEVICE HISTORY RECORD IS UNLIKELY TO ADD VALUE TO THE COMPLAINT INVESTIGATION REGARDING AN ALLEGATION OF PAIN.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE LEFT HIP.

    Description of Event or Problem · 1

    REVISION OF THE BELOW IMPLANTS. PINNACLE METAL LINER 36MMX50MM CODE 121887350 LOT 3000275. METAL HEAD 36MM +1.5 CODE 136551000 LOT 3003036. THE ORIGINAL SURGERY WAS (B)(6) 2009. THE REASON FOR REVISION WAS DUE TO PAIN BEING REPORTED BY THE PATIENT. A POLY LINER AND DELTA TS HEAD REPLACED THE EXTRACTED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234844 PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 3000275

    Patients

    Seq Age Sex Outcome Treatment
    1