BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18D-LRG

    MDR report key: 15474088 · Received September 23, 2022

    Report

    Report Number
    1818910-2022-18515
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    November 8, 2014
    Report Date
    September 22, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295175292
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). OCCUPATION: LAWYER. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH 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. 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 550524, LOT#: 3162636. AND NO NON-CONFORMANCES/MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    UNF AND PINNACLE NON MOM MEDICAL RECORDS RECEIVED. INITIAL REPORTED REASON FOR REVISION ARE THE FOLLOWING FRACTURED PROSTHETIC FEMORAL STEM, PAIN, DISCOMFORT, CLICKING SENSATION, HETEROTOPIC BONE OSSIFICATION, IMPINGEMENT, METALLOSIS, AWAITING FOR MEDICAL RECORDS REVIEW TASK FINDINGS. ONCE AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. DOI: (B)(6) 2010; DOR: (B)(6) 2014 ; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554525 S-ROM*SLEEVE PRX ZTT, 18D-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US 55-0524 3162636 10603295175292

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention ALTRX NEUT 36IDX58OD| ALTRX NEUT 36IDX58OD| DELTA CER HEAD 11/13 36MM +0| PINN CAN BONE SCREW 6.5MMX30MM| PINN CAN BONE SCREW 6.5MMX30MM| PINNACLE SECTOR II CUP 58MM| PINNACLE SECTOR II CUP 58MM| SROM STM STD 36+12L 13X18| SROM STM STD 36+12L 13X18