MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Model Number 04.01.0208

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 12/02/2022

Event Type  Injury  

Event Description

The patient had a primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting instability and the cause of instability is unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to anterior subluxation of the reverse revision components.The surgeon revised the glenosphere, insert, and metaphysis.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 5 december 2022 lot 2103687: (b)(4) items manufactured and released on 13-jul-2021.Expiration date: 2026-jun-24.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 device involved: batch review performed on 5 december 2022.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm lot.2103929 (k170452): (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-11.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 04.01.0208 LAT. GLENOSPHERE 39XØ24.5
• Type of Device: SHOULDER 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16015095
• MDR Text Key: 305816444
• Report Number: 3005180920-2022-00950
• Device Sequence Number: 1
• Product Code: HSD
• 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: 12/20/2022

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: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2103687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2021
• 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
• Patient Sex: Male