MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25; SHOULDER GLENOID BASEPLATE

Model Number	04.01.0190
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29 april 2022: lot 183703: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-aug-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.Additional device involved: batch review performed on 29 april 2022: reverse shoulder system 04.01.0171 glenosphere 42xø24.5 (k170452) lot 174732: (b)(4) items manufactured and released on 26-oct-2017.Expiration date: 2022-oct-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Picture analysis from medacta spine r&d project manager: the provided pictures show that the glenosphere was dislocated from the glenoid baseplate and that the black colored tissues suggest development of metallosis.The reverse liner was found massively worn out on the medial side.Visual inspection of the explants is required to proceed with the root cause investigation.
Event or Problem Description
The patient came in reporting pain and limited motion.X-rays revealed that the glenosphere disassociated from the glenoid.At 3 years and 4 months after the primary surgery, the surgeon revised the baseplate, liner, geosphere and metaphysis.The surgery was completed successfully.This had obviously been an issue for a long time.Notice the amount of metallosis, bone resorption and wear of components.The glenosphere was floating in the joint.There was no wear or damage to the glenosphere screw.
Additional Manufacturer Narrative
Pieces returned on june 21st 2022.Visual inspection performed by r&d project manager.The glenosphere back-surface shows two circular signs likely due to friction with two protruding screws.It is not possible to determine whether the screws were not fully seated during the primary surgery or if they backed out after time.The reverse liner presents massive wear on the medial side presumably due to friction with the scapula.The medial side of the reverse metaphysis is dull.Minor bone residuals are visible on the ha coated portion.The taper and the lateral surface of the baseplate are damaged due to repetitive friction with dissociated glenosphere.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25
• Common Device Name: SHOULDER GLENOID BASEPLATE
• 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: 14494641
• Report Number: 3005180920-2022-00397
• Device Sequence Number: 19432018
• Product Code: JWH
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 07/15/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 08/20/2023
• Device Model Number: 04.01.0190
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 183703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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: Male