BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSYS LNR AOX N 50X36

    MDR report key: 20817633 · Received December 2, 2024

    Report

    Report Number
    1818910-2024-24591
    Event Type
    Injury
    Date Received
    December 2, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LPH
    UDI-DI
    10603295501244
    PMA / PMN Number
    K221636
    Adverse Event
    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). 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11: ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND, NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM 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: THE PRODUCT INVESTIGATION FOUND, NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. 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 · 0

    SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED, FOR INCREASED PAIN AND SOME SWELLING IN THE RIGHT HIP. DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: REMOTE POSSIBILITY. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: ATTEMPT ASPIRATION OF HIP (PLANNED). PATIENT WAS SEEN IN THE CLINICAL SETTING ON (B)(6) 2024, AS PART OF HER STANDARD FOLLOW-UP. THREE WEEKS AFTER HER RIGHT HIP SURGERY, SHE GOT SEPTIC, HAD DIVERTICULITIS, PELVIC INFECTION AND A RESISTANT URINARY TRACT INFECTION. SHE HAS HAD A DIAGNOSED RIGHT GREATER TROCHANTER FRACTURE (NO SURGICAL TREATMENT PLANNED). SHE PRESENTS WITH PERSISTENT HIP PAIN TO THE TOUCH, ESPECIALLY ANTERIOR HIP, BUT NO SWELLING OR FLUID COLLECTION. HER X-RAYS AND LABS ARE NEGATIVE FOR ANY SIGNS OF IMPLANT FAILURE OR INFECTION. CLINICAL PLAN WAS TO ATTEMPT AN ASPIRATION OF HER HIP (MRI SHOWED A VERY SMALL FLUID COLLECTION IN THE JOINT) FOR EVALUATION OF POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326762 EMSYS LNR AOX N 50X36 HIP IMPLANT : ACETABULAR LINER LPH DEPUY IRELAND - 3015516266 4442562 10603295501244

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention