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

Catalog Number	04.01.0155
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 may 2024.Lot 2010663: 129 items manufactured and released on 12-feb-2021.Expiration date: 2026-jan-28.No anomalies found related to the problem.To date, 127 items of the same lot have been sold with no similar reported event during the period of review.Clincal evaluation performed by medical affairs department late infection in rsa, 2 years and 8 months after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional involved implants.Batch review performed on 23 may 2024 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003981 lot 2003981: 193 items manufactured and released on 06-may-2021.Expiration date: 2026-apr-27.No anomalies found related to the problem.To date, 178 items of the same lot have been sold with 1 similar reported event during the period of review.Batch review performed on 23 may 2024 on reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot.2010933 lot 2010933: 190 items manufactured and released on 23-dec-2020.Expiration date: 2025-dec-13.No anomalies found related to the problem.To date, 179 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 23 may 2024 on reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot.1909892 lot 1909892: 50 items manufactured and released on 24-mar-2020.Expiration date: 2025-mar-08.No anomalies found related to the problem.To date, 47 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 23 may 2024 on reverse shoulder system 04.01.0020 std humeral diaphysis - cemented - 14 (k170452) lot.2110749 lot 2110749: 8 items manufactured and released on 07-sep-2021.Expiration date: 2026-jul-29.No anomalies found related to the problem.To date, only this item of this lot has been sold.Batch review performed on 23 may 2024 on reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot.2003974 lot 2003974: 66 items manufactured and released on 25-feb-2021.Expiration date: 2026-feb-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with 1 similar reported event during the period of review.Batch review performed on 23 may 2024 on mectaplug 01.33.101 mectaplug pe size 1 () lot.2106019 lot 2106019: 214 items manufactured and released on 12-jul-2021.Expiration date: 2026-jun-30.No anomalies found related to the problem.To date, 213 items of the same lot have been sold with no similar reported event during the period of review.The device is not marketed in us.
Event or Problem Description
Revision surgery performed about 2 years and 8 months after the primary surgery due to infection (propioni-bacterium).All components revised.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
• Common Device Name: SHOULDER REVERSE SYSTEM 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: 19565507
• Report Number: 3005180920-2024-00412
• Device Sequence Number: 6305795
• 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: 2021
• 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): 06/19/2024

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 Expiration Date: 01/28/2026
• Device Catalogue Number: 04.01.0155
• Device Lot Number: 2010663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 87 KG