BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø54

    MDR report key: 8939222 · Received August 28, 2019

    Report

    Report Number
    3005180920-2019-00711
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    July 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713306
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 AUGUST 2019: LOT 181493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0092 METAL HUMERAL HEAD Ø44 (K170910) LOT. 167985. BATCH REVIEW PERFORMED ON 6 AUGUST 2019: LOT 167985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2017. EXPIRATION DATE: 2022-04-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED:ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT. 183786. BATCH REVIEW PERFORMED ON 6 AUGUST 2019: LOT 183786: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2018. EXPIRATION DATE: 2023-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 9 (K170910) LOT. 1710037. BATCH REVIEW PERFORMED ON 6 AUGUST 2019: LOT 1710037: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018. EXPIRATION DATE: 2023-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 172589. BATCH REVIEW PERFORMED ON 6 AUGUST 2019: LOT 172589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2017. EXPIRATION DATE: 2022-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 12 DAYS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734097 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø54 ANATOMICAL GLENOID KWS MEDACTA INTERNATIONAL SA 181493 07630040713306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention