BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS

    MDR report key: 16032690 · Received December 22, 2022

    Report

    Report Number
    3005180920-2022-00947
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    November 29, 2022
    Report Date
    December 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040712620
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022 : LOT 1710035: 70 ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 44 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022 ON ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT. 181485: LOT 181485: 198 ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2018. EXPIRATION DATE: 2023-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 176 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2022 ON ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD Ø46 (K170910) LOT. 167986: LOT 167986: 38 ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2017. EXPIRATION DATE: 2022-04-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 36 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON (B)(6) 2022 ON ANATOMICAL SHOULDER SYSTEM 04.01.0131 HC PEGGED GLENOID Ø46 (K170910) LOT. 182675: LOT 182675: 96 ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 89 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND POOR RANGE OF MOTION WAS OBSERVED. THE SURGEON AT ABOUT 3 YEARS AND 4 MONTHS POST PRIMARY DECIDED TO REMOVE ALL COMPONENTS EXCEPT THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2826567 ANATOMICAL SHOULDER SYSTEM HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS SHOULDER CEMENTLESS METAPHYSIS KWS MEDACTA INTERNATIONAL SA 04.01.0024 1710035 07630040712620

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention