MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM; SHOULDER LINER

Catalog Number	04.01.0126
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12-aug-2024 lot 2246174: (b)(4) items manufactured and released on 17-apr-2023.Expiration date: 2028-03-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 12-aug-2024: reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot 2243585: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 other similar reported events during the period of review.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2023.On the (b)(6) 2023, the patient came in reporting pain due to a joint luxation.The surgeon revised the glenosphere and liner.On (b)(6) 2024, the patient came in reporting pain due to a joint luxation.The surgeon revised for the second time the glenosphere and liner.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Note: this information was discovered after investigation with the branch related to the subsequent revision surgery (b)(6).Additional implant involved (not revised), batch review performed on 11 august 2025 reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot 2103993: (b)(4) items manufactured and released on 01-jul-2021.Expiration date: 16-jun-2026.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM
• Common Device Name: SHOULDER 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: 20154555
• Report Number: 3005180920-2024-00693
• Device Sequence Number: 8301114
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 04.01.0126
• Device Lot Number: 2246174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• 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 Sex: Male