BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX30MM

    MDR report key: 8668336 · Received June 4, 2019

    Report

    Report Number
    1818910-2019-95213
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    October 29, 2018
    Report Date
    May 16, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    UDI-DI
    10603295010159
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (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). CLINICAL NOTIFICATION RECEIVED FOR LEFT HIP REVISION TO ADDRESS PAINFUL LEFT HIP AND HIP DISLOCATION. DOI: (B)(6) 2015; DOR: (B)(6) 2018, (LEFT HIP). CUP, SCREWS, LINER, AND HEAD WERE REVISED. PRODUCTS PRESENT AT THE TIME OF THE REVISION SURGERY: CATALOG: 121732052, LOT: 641754, DEVICE: PINNACLE SECTOR SERIES GRIPTION ACETABULAR SHELL SZ 52MM; CATALOG: 121730500, LOT: D14092357, DEVICE: CANCELLOUS BONE SCREW 30MM; CATALOG: 121730500, LOT: D14092357, DEVICE: CANCELLOUS BONE SCREW 30MM; CATALOG: 122136052, LOT: 641776, DEVICE: PINNACLE ALTRX LINER NEUTRAL 36MM X 52MM; CATALOG: 157001110, LOT: 611722, DEVICE: SUMMIT STEM POROCOAT STD OFFSET SZ 5; CATALOG: 136550000, LOT: 7951473, DEVICE: ARTICUL/EZE HEAD METAL 36MM +1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460439 PINN CAN BONE SCREW 6.5MMX30MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDICS, INC. 1818910 D14092357 10603295010159

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R