BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    MDR report key: 8508148 · Received April 12, 2019

    Report

    Report Number
    3005180920-2019-00271
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 APRIL 2019: LOT 174650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEBRUARY-2018. EXPIRATION DATE: 2023-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (COMPLAINT (B)(4) [MDR 2018-01027). PRELIMINARY INVESTIGATION PERFORMED BY R&D SHOULDER MANAGER AFTER EVALUATING THE PICTURE OF THE EXPLANTED IMPLANTS, ONE CAN STATE THAT THE DIAPHYSIS SHOWS SIGNS OF BONE GROWTH IN THE CALCAR REGION, WHILE THE DISPLAYED PORTION OF THE GLENOID BASEPLATE DOES NOT SHOW BONE RESIDUALS. THE REMAINING IMPLANT COMPONENTS DO NOT SHOW ANY SIGNS OF RELEVANCE. NO FURTHER ASSESSMENT CAN BE MADE ON THE BASIS OF THE PROVIDED PICTURE. OTHER DEVICES WERE INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0186 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13 (K180089); LOT. 182495: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2018. EXPIRATION DATE: 2023-04-29. 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. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452); LOT. 175048: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-09-12. 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. REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452); LOT. 174737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2018. EXPIRATION DATE: 2022-12-27. 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. REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25 (K170452); LOT. 175039: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 2023-02-26. 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. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452); LOT. 174745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2018. EXPIRATION DATE: 2023-02-14. 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 DUE TO INFECTION AFTER ABOUT 2 MONTHS FROM THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303954 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 174650 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention