MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5

Catalog Number	04.01.0170
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2018; lot 163797: (b)(4) items manufactured and released on 20 december 2016 expiration date: 2021-10-10; 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.Other device involved: reverse shoulder system humeral reverse hc liner ø39/+3mm reference (k170452); lot 173396: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-05-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Clinical evaluation performed by medical affairs (b)(4) on 18 may 2018; dislocation of a rsa required ablation of both components and reposition of the scapular glenosphere.The humeral component 145° was replaced with a 155° to increase stability.The reported metallosis is a consequence of the dislocation and not a defect of the devices.There no indications that these devices malfunctioned to cause the adverse event.
Event or Problem Description
About 2 months after primary the surgeon revised the patient for a shoulder luxation.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7525809
• Report Number: 3005180920-2018-00344
• Device Sequence Number: 1626774
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 163797
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 77