MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

Catalog Number	04.01.0119
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 7 months from the primary, the patient came in reporting instability and the cause is unknown.The surgeon revised the lateralized glenosphere and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 january 2024.Lot 2218468: 75 items manufactured and released on 18-oct-2022.Expiration date: 2027-09-29.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional revised implant: batch review performed on (b)(6) 2024 on reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2247045, lot 2247045: 60 items manufactured and released on 22-feb-2023.Expiration date: 2028-02-05.No anomalies found related to the problem.To date, 42 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
• Common Device Name: SHOULDER SYSTEM HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18613586
• Report Number: 3005180920-2024-00013
• Device Sequence Number: 20724309
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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 Catalogue Number: 04.01.0119
• Device Lot Number: 2218468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female