BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 9/10 16X10X130 30

    MDR report key: 20924755 · Received December 13, 2024

    Report

    Report Number
    1818910-2024-25339
    Event Type
    Injury
    Date Received
    December 13, 2024
    Report Date
    December 13, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 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. CORRECTED: D4 (PRIMARY UDI NUMBER), H8.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A THA WITH THE S-ROM STEM FOR RIGHT HIP JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE STEM WAS BROKEN AT THE BASE. SINCE THE PATIENT HAS NO SUBJECTIVE SYMPTOMS, A REVISION SURGERY IS NOT PERFORMED. THE SURGEON IS FOLLOWING UP THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. 1. PRODUCT CODE: 152190055/LOT NUMBER: 2900923/QUANTITY: (B)(4). 2. PRODUCT CODE: 521463/LOT NUMBER: 3023960/QUANTITY: (B)(4). 3. PRODUCT CODE: 900529210/LOT NUMBER: 2934430/QUANTITY: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416598 SROM 9/10 16X10X130 30 S-ROM HIP SYSTEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US 2934430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention