BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 58MM

    MDR report key: 8617756 · Received May 16, 2019

    Report

    Report Number
    1818910-2019-93758
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    February 12, 2018
    Report Date
    January 13, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    PFS ALLEGES ANXIETY. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR INFECTION INFLAMMATORY REACTION DUE TO JOING PROSTHESIS LEFT HIP. OPERTATIVE NOTES REPORTED THAT THERE WAS A LARGE EFFUSION WITH COPIOUS LIGHT BROWN FLUID.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, INFECTION, PARTIAL OR COMPLETE LOSS OF MOBILITY AND LOSS OF RANGE OF MOTION. DOI: (B)(6) 2017 - DOR: (B)(6) 2018 (LEFT HIP). PREVIOUS REVISION ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408731 PINNACLE 300 ACET CUP 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS, INC. 181891 DB7E71000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention