MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5; SHOULDER REVERESE GLENOSPHERE

Catalog Number 04.01.0208

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/12/2023

Event Type  Injury  

Event Description

At 1 month and a half from the primary, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on (b)(6) 2023: lot 2247046: (b)(4) items manufactured and released on 23-feb-2023.Expiration date: 2028-02-05.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.Additional device involved batch review performed on (b)(6) 2023: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2211667: (b)(4) items manufactured and released on 06-sept-2022.Expiration date: 2027-08-16.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.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
• Type of Device: SHOULDER REVERESE GLENOSPHERE
• 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: 17918325
• MDR Text Key: 325443700
• Report Number: 3005180920-2023-00765
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• 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: 10/12/2023

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: 04.01.0208
• Device Lot Number: 2247046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• 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 Sex: Male