BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE STD D38MM

    MDR report key: 11828514 · Received May 14, 2021

    Report

    Report Number
    1818910-2021-10380
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 3, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    PHX
    UDI-DI
    10603295027768
    PMA / PMN Number
    K120174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : PC-(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 : 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXTENSION TO THE SURGERY TIME.

    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

    REVISION OF DELTA EXTEND, DONE 8 WEEKS AGO BY THE SAME SURGEON AT THE SAME FACILITY. DID THE CASE WITH A DIFFERENT APPROACH, SO DIDN'T SPOT ADDED OSTEOPHYTES ON THE GLENOID THAT HE BELIEVED CAUSED THE IMPLANT TO DISLOCATE. CHANGED GLENOSPHERE SIZE, AS WELL AS POLY AND STEM POSITION. HARDWARE/EXPLANT REMOVAL DUE TO DISLOCATION AND PAIN. REVISION (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723708 DXTEND GLENOSPHERE STD D38MM DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE PHX DEPUY ORTHOPAEDICS INC US 130760138 5368995 10603295027768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DXTEND HIGHMO PE CUP D38 +9MM| DXTEND METAGLENE| DXTEND MOD EPI 1 ECC RIGHT HA| DXTEND MODULAR HUM STEM D10 HA| DXTEND SCREW LOCK D4.5X24MM| DXTEND SCREW LOCK D4.5X24MM| DXTEND SCREW NO LOCK D4.5X18MM| DXTEND SCREW NO LOCK D4.5X18MM