MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27; SHOULDER GLENOSPHERE

Catalog Number	04.01.0174
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
About 2 years after the primary surgery, xrays showed that the glenosphere eccentricity is upside down and that the glenosphere is dissociated from the baseplate.Revision surgery date is not defined yet.Glenosphere guide was not used during the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 27 march 2024: lot 2103684: (b)(4) items manufactured and released on 04-may-2021.Expiration date: 2026-apr-20.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 device invovled: batch review performed on 27 march 2024: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot 2110377: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-nov-09.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.Clinical evaluation performed by medacta medical affairs manager: two years after the primary surgery, the patient underwent radiographic analysis due to pain and rom decrease.From the radiographic images it is visible that the glenosphere eccentricity is upside down.The glenosphere dissociated from the baseplate.No revision surgery date is defined yet.Since the glenosphere guide was not used during the primary surgery, it may be possible that the glenosphere did not reach its final seating and with time the implant dissociated from the baseplate.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42XØ27
• 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: 19151098
• Report Number: 3005180920-2024-00230
• Device Sequence Number: 9420293
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2026
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 2103684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2021
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Male