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

Catalog Number	04.01.0207
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 11 months after the primary, the patient came in reporting pain due to a loose glenosphere and the cause is unknown.From the x-rays a broken screw can be observed.The surgeon revised the liner, metaphysis and glenosphere.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 february 2024: lot 2115429: 41 items manufactured and released on 07-apr-2022.Expiration date: 2027-02-02.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affair director: revision about 1 year 11 months after the primary rsa due to a loose glenosphere and the cause is unknown.From the radiographic images it is visible that a screw is broken.It may be possible that the humeral stem may have impinged within the glenosphere and during abduction may have pried and moved the glenosphere and broken the screw.There is no explicit report of a traumatic event, but the radiographic situation is compatible with sequelae of a trauma.There is no reason to suspect a faulty device.Additional implant involved, batch review performed on 22 march 2024: reverse shoulder system glenoid polyaxial locking screw - l30 (k170452) lot 2118702: (b)(4) items manufactured and released on 09-febr-2022.Expiration date: 2027-01-26.No anomalies found related to the problem.To date, 194 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
• Common Device Name: 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18959438
• Report Number: 3005180920-2024-00124
• Device Sequence Number: 13102580
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 04.01.0207
• Device Lot Number: 2115429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2022
• 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