MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

Model Number	04.01.0155
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, revision surgery performed following deep infection.The surgeon revised glenosphere, liner and glenoid components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 april 2023.Lot: 2215289: (b)(4) items manufactured and released on 16-nov-2022.Expiration date: 2027-11-02.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 component involved: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot: 2216008 lot: 2216008: (b)(4) items manufactured and released on 08-oct-2022.Expiration date: 2027-08-24.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.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot: 2237972 lot: 2237972: (b)(4) items manufactured and released on 04-nov-2022.Expiration date: 2027-10-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot: 2242289 lot: 2242289: (b)(4) items manufactured and released on 21-dec-2022.Expiration date: 2027-12-01.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.Reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot: 2237099 lot: 2237099: (b)(4) items manufactured and released on 10-oct-2022.Expiration date: 2027-09-22.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 GLENOID BASEPLATE Ø27X25
• Common Device Name: GLENOID BASEPLATE
• 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: 16731287
• Report Number: 3005180920-2023-00293
• Device Sequence Number: 17853292
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• 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: 2023
• 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): 04/13/2023

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 Model Number: 04.01.0155
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2215289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• 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 Sex: Unknown