MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38

Catalog Number	04.01.0163
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2023 lot 2315020: (b)(4) items manufactured and released on 18-aug-2023.Expiration date: 2028-07-23.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.Other devices involved: reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 2319630: (b)(4) items manufactured and released on 05-oct-2023.Expiration date: 2028-09-13.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.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2311732: (b)(4) items manufactured and released on 05-jul-2023.Expiration date: 2028-06-20.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2313417: (b)(4) items manufactured and released on 27-sept-2023.Expiration date: 2028-09-07.No anomalies found related to the problem.To date, 98 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot 2317717: 40 items manufactured and released on 02-nov-2023.Expiration date: 2028-10-15.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.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2308778: 90 items manufactured and released on 23-aug-2023.Expiration date: 2028-08-01.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.
Event or Problem Description
The patient had primary surgery on (b)(6) 2023.Revision surgery due to infection was performed on (b)(6) 2023.Glenosphere and liner revised successfully.On (b)(6) 2023, the patient underwent revision surgery due to infection.The surgeon revised all the components successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38
• Common Device Name: GLENOID POLYAXIAL LOCKING SCREW
• 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: 18371303
• Report Number: 3005180920-2023-01050
• Device Sequence Number: 20785041
• Product Code: PHX
• UDI-Device Identifier: 07630040706506
• UDI-Public: 07630040706506
• 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): 12/21/2023

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 Catalogue Number: 04.01.0163
• Device Lot Number: 2315020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 87 KG