BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM

    MDR report key: 14159950 · Received April 20, 2022

    Report

    Report Number
    3005180920-2022-00269
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706339
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 MARCH 2022. LOT 2006597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-26. 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D SHOULDER MANAGER: THE PICTURES OF THE EXPLANTS DO NOT SHOW ANY SIGNS OF DAMAGE. BONE FRAGMENTS ARE VISIBLE AROUND THE GLENOID VAULT IN THE PROVIDED CT IMAGE. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE THEIR EXACT LOCATION, NOR IDENTIFY THEM AS A POSSIBLE CAUSE OF THE EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW DAYS AFTER PRIMARY RSA; LUXATION OCCURS. ONLY ONE CT FIXED IMAGE WAS SUPPLIED, WHICH MAKES A CLEAR UNDERSTANDING OF THE POSSIBLE CAUSES VERY DIFFICULT. THE REPORT MENTIONS THE POSSIBILITY OF BONE FRAGMENTS AROUND THE GLENOSPHERE: THIS WOULD EXPLAIN THE DECISION BY THE SURGEON TO REPLACE METAPHYSIS, INSERT AND GLENOSPHERE, BUT WE COULD NOT UNDERSTAND THE POSSIBLE CAUSES FOR THIS SITUATION AND THE DOCUMENTATION SUPPLIED IS NOT SUFFICIENT FOR A DEFINITIVE ANALYSIS. WE SEE NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS PROBLEM. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22 MARCH 2022: REVERSE SHOULDER SYSTEM 04.01.0174 GLENOSPHERE 42X27 (K170452) LOT. 2103685 LOT 2103685: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2021. EXPIRATION DATE: 2026-05-31. 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 · 0

    REVISION OF METAPHYSIS, GLENOSPHERE, AND LINER ALMOST 1 MONTH AFTER PRIMARY FOLLOWING SHOULDER LUXATION. MAYBE THERE WERE BONE PIECES AROUND THE GLENOSPHERE THAT CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630962 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0126 2006597 07630040706339

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention