MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM; SHOULDER HUMERAL LINER

Catalog Number	04.01.0116
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2019.Lot 173414: 80 items manufactured and released on 21-june-2017.Expiration date: 05.06.2022.No anomalies found related to the problem.To date, 40 items of the same lot have been already sold without other similar reported events.Batch review performed on 28 november 2019.Reverse shoulder system 04.01.0178 glenosphere 32xø24.5 lot.179968 (k170452) lot 179968: 74 items manufactured and released on 18-april-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, 30 items of the same lot have been already sold with one other similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a shoulder dislocation 1 month after primary.The surgeon revised the liner and the surgery was completed successfully.New liner: humeral reverse hc liner ø32/+6mm.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+0MM
• Common Device Name: SHOULDER HUMERAL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9416218
• Report Number: 3005180920-2019-01026
• Device Sequence Number: 2579045
• Product Code: PHX
• UDI-Device Identifier: 07630040706230
• UDI-Public: 07630040706230
• Combination Product (Y/N): N
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 06/05/2022
• Device Catalogue Number: 04.01.0116
• Device Lot Number: 173414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• 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