BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 19309844 · Received May 14, 2024

    Report

    Report Number
    1818910-2024-10443
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 14, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION:- PINNACLE MTL INS NEUT40IDX56OD. PRODUCT CODE:- 121887456. LOT NO:- 3002294. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 24SEPT2009. EXPIRY DATE:- SEPTEMBER 2014. IFU REFERENCE:- 78004780. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT DESCRIPTION:- PINNACLE MTL INS NEUT40IDX56OD. PRODUCT CODE:- 121887456. LOT NO:- 3002294. QUANTITY OF MANUFACTURED:- (B)(4). DATE OF MANUFACTURING:- 24SEPT2009. EXPIRY DATE:- SEPTEMBER 2014. IFU REFERENCE:- 78004780. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2009, DATE OF EVENT: 15 APR 2024, (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649245 PINNACLE MTL INS NEUT40IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 3002294

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention 11/13 S-ROM 40MM M SPEC+3| APEX HOLE ELIM POSITIVE STOP| PINNACLE 100 ACET CUP 56MM| S-ROM*SLEEVE PRX ZTT, 16D-LRG| SROM STM ST,36+6L NK,11X16X150