MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM; SHOULDER REVERSE LINER

Catalog Number 04.01.0111

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 09/18/2023

Event Type  Injury  

Event Description

At about 1 month after the primary, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the metaphysis, liner, and glenosphere.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 19 september 2023: lot 2304475: (b)(4) items manufactured and released on 10-july-2023.Expiration date: 2028-06-20.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.Additional device involved: batch review performed on 19 september 2023: reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot 2243584a: (b)(4) items manufactured and released on 10-may-2023.Expiration date: 2028-04-18.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 medacta medical affairs manager: revision 1 month after the primary rsa, due to instability reported by the patient.With the information at hand it is not possible to determine the cause of this instability.However, it may be possible that the cause could be insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
• Type of Device: SHOULDER 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: 17904607
• MDR Text Key: 325279818
• Report Number: 3005180920-2023-00775
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2023

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: 04.01.0111
• Device Lot Number: 2244281
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2023
• 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