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	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 november 2023.Lot 2115605: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-jan-03.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 item involved in the complaint, batch review performed on 30 november 2023: reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot.179112a.Lot 179112a: (b)(4) items manufactured and released on 25-jan-2022.Expiration date: 2027-jan-11.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.Lot 179112: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-mar-14.No anomalies found related to the problem.To date, 101 items of the same lot have been sold with 1 similar reported event during the period of review.Lot 179112b: (b)(4) items manufactured and released on 02-dec-2022.Expiration date: 2027-nov-16.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.
Event or Problem Description
About 1 year and 8 months after the primary surgery, the patient experienced two episodes of spontaneous dislocation.Pre-revision testing by the surgeon with excellent stability in all movements.Posterior dislocation once the patient is asleep with muscle relaxation.Liner revised with a humeral reverse pe liner 36mm +6mm (155).

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
• Common Device Name: 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: 18356297
• Report Number: 3005180920-2023-01007
• Device Sequence Number: 6923898
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 2115605
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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 Age: 70 YR
• Patient Sex: Female