MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

Model Number	04.01.0154
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 175034: 100 items manufactured and released on 27-nov-2017.Expiration date: 2022-nov-09.No anomalies found related to the problem.To date, 60 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 5 months after the primary surgery, the patient came in for a post-op appointment and it was observed that the baseplate position was malaligned inferiorly.According to the revision surgeon, the implant was malpositioned during the primary surgery.The surgeon decided to revise the metaphysis, and used competitor's baseplate and glenosphere to revise inclination/angle of the implant.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15
• Common Device Name: 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: 14942677
• Report Number: 3005180920-2022-00522
• Device Sequence Number: 17266626
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 11/09/2022
• Device Model Number: 04.01.0154
• Device Catalogue Number: 04.01.0154
• Device Lot Number: 175034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2017
• 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