BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 9083539 · Received September 18, 2019

    Report

    Report Number
    1818910-2019-105278
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    August 26, 2019
    Report Date
    August 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295060086
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 · 1

    SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR GREATER TROCHANTERIC FRACTURE: PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THIS EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT HIP) DEPUY COMPONENTS: CATALOG ID: 121720500. LOT: D19014083. DESCRIPTION: PINNACLE CANCELLOUS BONE SCREW 6.5 MM X 20 MM. CATALOG ID: 121725500. LOT: D18112328. DESCRIPTION: CANCELLOUS BONE SCREW 25MM. CATALOG ID: 136536310. LOT: 9228423. DESCRIPTION: BIOLOX DELTA FEMORAL HEAD CERAMIC 36MM +1.5. CATALOG ID: 122136452. LOT: J47H21. DESCRIPTION: PINNACLE ALTRX 52MM X 36MM +4 NEUTRAL. CATALOG ID: 157011135. LOT: J41Y23. DESCRIPTION: SUMMIT STEM POROCOAT HIGH OFFSET SZ 7. CATALOG ID: 121722052. LOT: J45F03. DESCRIPTION: PINNACLE SHELL SECTOR 52MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875966 SUMMIT POR TAPER SZ7 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US J41Y23 10603295060086

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ALTRX +4 NEUT 36IDX52OD| DELTA CER HEAD 12/14 36MM +1.5| PINNACLE BONE SCREW 20 MM| PINNACLE BONE SCREW 25 MM| PINNACLE SECTOR II CUP 52MM