MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

Model Number	04.01.0173
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 january 2022.Lot 1909882: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-mar-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Clinical evaluation performed by medical affairs director.About 6 months after primary rsa, the glenosphere detaches from the baseplate and will likely require revision.As the revision surgery has not been performed yet, no direct examination of explants could be performed at the time of this report.The radiographs supplied do not carry a date, but in spite of the low quality of the images it appears that the glenosphere is not fully seated.We cannot determine if this suboptimal position has developed over time or if it was the case immediately after surgery.Incomplete seating of the glenosphere is the most probable cause for the subsequent detachment, but of course no definite conclusion can be drawn without explants to be properly examined.Additional items involved in the event, batch review performed on 19 january 2022: reverse shoulder system 04.01.0177 glenosphere screw (k170452) lot.189743 lot 189743: (b)(4) items manufactured and released on 31-oct-2018.Expiration date: 2023-oct-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot.1910865 lot 1910865: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-apr-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
About 6 months after the primary surgery, the screw of the glenosphere became loose and the glenosphere was not fixed anymore.The revision surgery will be performed.The date is undecided at the moment.
Additional Manufacturer Narrative
About 6 months after the primary surgery, the screw of the glenosphere became loose and the glenosphere was not fixed anymore.Revision surgery performed on (b)(6) 2022.
Event or Problem Description
About 6 months after the primary surgery, the screw of the glenosphere became loose and the glenosphere was not fixed anymore.Revision surgery performed on (b)(6) 2022.
Additional Manufacturer Narrative
Devices returned on 08-april-2022 and analyzed.Visual inspection performed by r&d project manager mild circumferential signs are visible on the convex back surface of the glenosphere, probably due to friction with a peripheral glenoid screw.It is not possible to state whether the screw was positioned proud form the baseplate after the primary surgery or it backed out in the following months.The glenosphere screw shows circular scratches on the outer surface.No action is suggested.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13532819
• Report Number: 3005180920-2022-00101
• Device Sequence Number: 14497746
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/12/2022

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: 03/16/2025
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 1909882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022; 01/18/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2020
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian