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

Catalog Number	04.01.0154
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months from the primary, revision surgery due to infection.The surgeon revised all the implants.
Additional Manufacturer Narrative
Batch review performed on 16-aug-2023.Lot 2242347: (b)(4) items manufactured and released on 25-jan-2023.Expiration date: 2028-01-10.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 reviews performed on 16-aug-2023: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot 2240240: (b)(4) items manufactured and released on 28-nov-2022.Expiration date: 2027-11-16.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.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2244673: (b)(4) items manufactured and released on 27-dic-2022.Expiration date: 2027-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot 2244669: (b)(4) items manufactured and released on 27-dec-2022.Expiration date: 2027-12-05.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.Reverse shoulder system 04.01.0006 std humeral diaphysis - cementless - 11 (k170452) lot 2117678: (b)(4) items manufactured and released on 21-mar-2022.Expiration date: 2027-03-06.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2219868: (b)(4) items manufactured and released on 17-jan-2023.Expiration date: 2027-12-27.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.Review for reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2237445: (b)(4) items manufactured and released on 4-nov-2022.Expiration date: 2027-10-17.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 Manufacturer Narrative
Visual inspection performed by r&d project manager: from the visual inspection of the returned devices, it is possible to establish taht the explants do not show anything to be highlighted.Information of the fu: data of returned devices: 20 september 2023.Visual inspection of the devices.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15
• Common Device Name: SHOULDER GLENOID BASEPLATE
• 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: 17669144
• Report Number: 3005180920-2023-00681
• Device Sequence Number: 17723217
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/18/2023

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 Catalogue Number: 04.01.0154
• Device Lot Number: 2242347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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: Unknown