BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48

    MDR report key: 8877722 · Received August 9, 2019

    Report

    Report Number
    3005180920-2019-00668
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713276
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25-JULY-2019: LOT 181490: (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)(6) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: UNEXPECTED EARLY PAIN IN PRIMARY TSA AFTER LESS THAN 1 YEAR. THE SOURCE OR CAUSE OF PAIN CANNOT BE ASCERTAINED WITH THE INFORMATION SUPPLIED - THE SYSTEM LOOKS CORRECTLY IMPLANTED AND NO TRAUMA HAS BEEN REPORTED. WE DO NOT KNOW IF THE REVISION SURGEON CHANGED POSITION OR TENSION BECAUSE WE HAVE NO POST-REVISION XRAYS. WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS ADVERSE EVENT. ADDITIONAL IMPLANT: ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 9 (K170910), LOT. 1710037. BATCH REVIEW PERFORMED ON 25-JULY-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 OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT: ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910), LOT. 181485. BATCH REVIEW PERFORMED ON 25-JULY-2019: LOT 181485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-MAY-2018. EXPIRATION DATE: 2023-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT :ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD Ø46 (K170910) LOT. 167986. BATCH REVIEW PERFORMED ON 25-JULY-2019: LOT 167986: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-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 OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 11 MONTHS FROM THE PRIMARY DUE TO PAIN (THE CAUSE OF THE PAIN IS UNKNOWN, THERE WAS NO TRAUMA). THE SURGEON REVISED THE HUMERAL HEAD, DOUBLE ECCENTER, HUMERAL METAPHYSIS, AND HC PEGGED GLENOID SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671738 ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48 ANATOMICAL GLENOID KWS MEDACTA INTERNATIONAL SA 181490 07630040713276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention