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

Catalog Number	04.01.0169
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The fixation glenosphere screw and the glenosphere rotated at the same time while tightening and the glenoid bone fractured.It's unknown whether the fracture occurred during the seating of the baseplate or the glenosphere.Bone graft used to complete the surgery, 27mm baseplate and 36xø27 glenosphere successfully implanted.
Additional Manufacturer Narrative
Batch review performed on 21 aug 2024: lot 2402049: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved batch review performed on 21 aug 2024 reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot 2403066: (b)(4) items manufactured and released on 10-may-2024.Expiration date: 2029-05-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 21 aug 2024 reverse shoulder system 64.01.9009 sf glenosphere screw lot 2403624: (b)(4) items manufactured and released on 24-april-2024.No anomalies found related to the problem.Clinical evaluation performed by medacta medical affairs manager: during an rsa the glenosphere rotated while tightening the screw and at least one screw broke and the glenoid bone fractured.According to report, it's unknown whether the fracture occurred during the seating of the baseplate or the glenosphere.It may be possible that the bone quality was very low and tightening the screws exceeded the bone strength.Visual inspection performed by medacta r&d shoulder manager: the implants do not show any sign of damage.Given the information at hand it is not possible to determine what caused the glenoid fracture not when it occurred.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM 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: 20188176
• Report Number: 3005180920-2024-00723
• Device Sequence Number: 15461850
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 2402049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian