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

Model Number 04.01.0207

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 february 2023.Lot 2207983: (b)(4) items manufactured and released on 10-aug-2022.Expiration date: 2027-07-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs manager: revision about 2 months after the primary rsa due to luxation.The surgeon revised successfully the glenosphere, liner, metaphysis and diaphysis.These events are normal originated by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Additional item involved in the event, batch review performed on 09 february 2023: reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot.2005453 lot 2005453: (b)(4) items manufactured and released on 12-aug-2020.Expiration date: 2025-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 2 months after the primary, revision surgery due to shoulder luxation.The surgeon revised successfully the glenosphere, liner, metaphysis and diaphysis.

• 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: 16501462
• MDR Text Key: 310862395
• Report Number: 3005180920-2023-00119
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K193175
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2207983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2022
• 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: Female