MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM; SHOULDER HUMERAL LINER

Model Number 04.01.0125

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 02/27/2023

Event Type  Injury  

Event Description

At about 12 days after the primary surgery, the patient came in reporting instability and the cause is unknown.The surgeon revised the liner (+0mm) with a thicker one (+3mm) and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on (b)(6) 2023: lot 2114981: 28 items manufactured and released on (b)(6) 2021.Expiration date: 2026-12-01.No anomalies found related to the problem.To date, 21 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM
• Type of Device: SHOULDER HUMERAL LINER
• 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: 16596963
• MDR Text Key: 311827375
• Report Number: 3005180920-2023-00170
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/23/2023

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 Model Number: 04.01.0125
• Device Catalogue Number: 04.01.0125
• Device Lot Number: 2114981
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2021
• 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