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

Catalog Number 04.01.0163

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/06/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 331084914
• Report Number: 3005180920-2023-01050
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706506
• UDI-Public: 07630040706506
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0163
• Device Lot Number: 2315020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 87 KG