MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM; HUMERAL REVERSE LINER

Catalog Number	04.01.0124
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2019.Lot 175050: 52 items manufactured and released on 27-sep-2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, 28 items of the same lot have been already sold with another similar reported event.Other device involved in the event: reverse shoulder system 04.01.0173 glenosphere 39xø27 lot.179114 (k170452).Batch review performed on 28 november 2019.Lot 179114: 122 items manufactured and released on 26-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, 66 items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a dislocation of the shoulder.The cause of the dislocation is unknown.The surgeon revised the glenoid baseplate, the humeral metaphysis, glenosphere, and all glenoid screws 2 months after primary surgery.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• Common Device Name: HUMERAL REVERSE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9464994
• Report Number: 3005180920-2019-01065
• Device Sequence Number: 19291200
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 175050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/13/2019
• 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