MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5; SHOULDER GLENOSPHERE

Model Number 04.01.0207

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 december 2022: lot 2004002: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-03-16.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 components involved: reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot.2103236: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-05-06.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° lot.2003875: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-03-16.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.

Event Description

The patient came in reporting instability due to laxity.At about 1 year and 2 months post primary the surgeon revised the 36xø24.5mm glenosphere with a 39xø24.5mm glenosphere, revised the ø36/+3mm liner with a ø39/+0mm and revised the +0mm/0° metaphysis with a +9mm/0° metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
• 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: 15994321
• MDR Text Key: 305581881
• Report Number: 3005180920-2022-00962
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2004002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2021
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Race: White