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

Model Number	04.01.0126
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2022.Lot 2006597: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d shoulder manager: the pictures of the explants do not show any signs of damage.Bone fragments are visible around the glenoid vault in the provided ct image.However, it is not possible to determine their exact location, nor identify them as a possible cause of the event.Clinical evaluation performed by medical affairs director: few days after primary rsa; luxation occurs.Only one ct fixed image was supplied, which makes a clear understanding of the possible causes very difficult.The report mentions the possibility of bone fragments around the glenosphere: this would explain the decision by the surgeon to replace metaphysis, insert and glenosphere, but we could not understand the possible causes for this situation and the documentation supplied is not sufficient for a definitive analysis.We see no reason to suspect a faulty device at the origin of this problem.Additional item involved in the event, batch review performed on 22 march 2022: reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot.2103685 lot 2103685: (b)(4) items manufactured and released on 16-jun-2021.Expiration date: 2026-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision of metaphysis, glenosphere, and liner almost 1 month after primary following shoulder luxation.Maybe there were bone pieces around the glenosphere that contributed to this event.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM
• Common Device Name: HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14159950
• Report Number: 3005180920-2022-00269
• Device Sequence Number: 11499445
• Product Code: PHX
• UDI-Device Identifier: 07630040706339
• UDI-Public: 07630040706339
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 11/26/2025
• Device Model Number: 04.01.0126
• Device Catalogue Number: 04.01.0126
• Device Lot Number: 2006597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White