MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0; SHOULDER HUMERAL METAPHYSIS

Model Number	04.01.0111
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 september 2021: lot 2001145: (b)(4) items manufactured and released on 26-ago-2020.Expiration date: 2025-ago-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.Additional devices involved: batch reviews performed on 23 september 2021: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2100435: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-mar-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot 2004000: (b)(4) items manufactured and released on 24-mar-2021.Expiration date: 2026-mar-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting lateral instability and the cause of the instability is laxity.About 1 month and a half after the primary surgery, the surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0
• Common Device Name: SHOULDER HUMERAL METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12655740
• Report Number: 3005180920-2021-00812
• Device Sequence Number: 17196621
• Product Code: PHX
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• 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: 2021
• Device Explanted Year: 2021
• 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): 10/19/2021

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: 08/18/2025
• Device Model Number: 04.01.0111
• Device Catalogue Number: 04.01.0111
• Device Lot Number: 2001145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention