MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER HUMERAL REVERSE LINER

Catalog Number 04.01.0120

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 08/04/2023

Event Type  Injury  

Event Description

At about 3 months from the previous revision, the patient came in reporting pain, due to a dislocation of the liner from the glenosphere, and the cause of the dislocation is unknown.The surgeon revised the reverse metaphysis and revised the 3mm liner with a 6mm liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 07-aug-2023: lot 2242695: (b)(4) items manufactured and released on 10-feb-2023.Expiration date: 2028-01-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional device involved: batch review performed on 07-aug-2023: reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot 2217134: (b)(4) items manufactured and released on 23-sept-2022.Expiration date: 2027-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM
• Type of Device: SHOULDER HUMERAL REVERSE 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: 17641504
• MDR Text Key: 322163257
• Report Number: 3005180920-2023-00658
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2023

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: 04.01.0120
• Device Lot Number: 2242695
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2023
• 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: 82 YR
• Patient Sex: Male
• Patient Race: White