MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+6MM; SHOULDER REVERSE SYSTEM HIGHCROSS LINER

Catalog Number	04.01.0127
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 week after the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.The surgeon revised the glenosphere, metaphysis, baseplate, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 may 2024 lot 2307538: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 2028-07-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved implant batch review performed on 24 may 2024 on reverse shoulder system 04.01.0171 glenosphere 42xø24.5 (k170452) lot.179966e lot 179966e: (b)(4) items manufactured and released on 11-march-2024.Expiration date: 2029-02-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+6MM
• Common Device Name: SHOULDER REVERSE SYSTEM HIGHCROSS 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: 19517429
• Report Number: 3005180920-2024-00419
• Device Sequence Number: 14972686
• Product Code: PHX
• UDI-Device Identifier: 07630040706346
• UDI-Public: 07630040706346
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/12/2024

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: 04.01.0127
• Device Lot Number: 2307538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: 60 YR
• Patient Sex: Male