MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø42; ANATOMICAL SHOULDER GLOENOID COMPONENT

Model Number	04.01.0129
Medical Device Problem Codes	Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2113347: (b)(4) items manufactured and released on 19-ott-2021.Expiration date: 2026-10-05.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.
Event or Problem Description
Total anatomic shoulder was implanted on (b)(6) 2022.Anatomic humeral head (48mm) and poly glenoid component (42mm) were implanted, this coupling is not allowed as per medacta anatomic shoulder surgical technique.At 9 months from primary surgery the patient had pain and shoulder instability.The surgeon revised all components and during revision it was found that the glenoid was mobilized from bone.Reverse shoulder system implanted successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.About 9 months after primary tsa, revision is required for joint instability.Indeed, the original surgery involved a 48mm head coupled with a 42mm glenoid, combination that is off-label and that can lead to some instability.In addition to that, the anomalous loading conditions may also hinder the stability of the cemented glenoid component.We therefore think that the most probable cause for this adverse event is the mismatch between head and glenoid, and we see no reason to suspect a malfunctioning device.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø42
• Common Device Name: ANATOMICAL SHOULDER GLOENOID COMPONENT
• 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: 16743206
• Report Number: 3005180920-2023-00241
• Device Sequence Number: 5435505
• Product Code: KWS
• UDI-Device Identifier: 07630040713245
• UDI-Public: 07630040713245
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2026
• Device Model Number: 04.01.0129
• Device Catalogue Number: 04.01.0129
• Device Lot Number: 2113347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown