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

Catalog Number	04.01.0211
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reverse shoulder revision surgery on the left side about 11 months after the primary surgery.Explantation of all reverse shoulder implants from the primary surgery.Melted bone graft and presence of macroscopically infected tissue.Implantation of new reverse shoulder components.
Additional Manufacturer Narrative
Batch review performed on 6 march 2024: lot 2003768a: (b)(4) items manufactured and released on 28-jan-2021.Expiration date: 2026-jan-14.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 involved: batch review performed on 6 march 2024 reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot 2215288: (b)(4) items manufactured and released on 27-oct-2022.Expiration date: 2027-oct-23.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 04.01.0183 short humeral diaphysis - cementless - 10 (k180089) lot 2236659: (b)(4) items manufactured and released on 26-oct-2022.Expiration date: 2027-oct-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.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) 2240571: 50 items manufactured and released on 24-nov-2022.Expiration date: 2027-nov-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2115608: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2027-jan-02.No anomalies found related to the problem.To date, all 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 2212556: (b)(4) items manufactured and released on 08-nov-2022.Expiration date: 2027-oct-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2217130: (b)(4) items manufactured and released on 13-sep-2022.Expiration date: 2027-aug-28.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.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27
• 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: 18977238
• Report Number: 3005180920-2024-00151
• Device Sequence Number: 6498200
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 03/26/2024

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: 01/26/2014
• Device Catalogue Number: 04.01.0211
• Device Lot Number: 2003768A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 96 KG