BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE DM LINER 48_41

    MDR report key: 19271579 · Received May 8, 2024

    Report

    Report Number
    1818910-2024-10176
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 28, 2024
    Report Date
    May 8, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    UDI-DI
    10603295520177
    PMA / PMN Number
    K200854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION:- PINNACLE DM LINER 48_41. PRODUCT CODE:- 121848041. LOT NO:- 9811225. QUANTITY OF MANUFACTURED:-(B)(4). DATE OF MANUFACTURING:-10-JUN-2021. EXPIRY DATE:-31-MAY-2031. 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 DM LINER 48_41. PRODUCT CODE:- 121848041. LOT NO:- 9811225. QUANTITY OF MANUFACTURED:-(B)(4). DATE OF MANUFACTURING:-10-JUN-2021. EXPIRY DATE:-31-MAY-2031. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO SURGICAL DELAY. B. WHAT IS THE REASON FOR REVISION? INFECTION. C. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS/CONSEQUENCES THAT LED TO THE REVISION SURGERY? INFECTION. D. WAS THERE AN INFECTION THAT LED TO THE WASHOUT? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT BECAME INFECTED. DR WASHED IT OUT AND REPLACED THE LINERS AND HEAD. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT HIP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753702 PINNACLE DM LINER 48_41 TOTAL HIP JOINT REPLACEMENT PROSTHESIS LPH DEPUY IRELAND - 9616671 9811225 10603295520177

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention ARTICUL/EZE BALL 22.225+4 NK| BI MENTUM ALTRX LNR 41 22