MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27

Model Number	04.01.0211
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2020: lot 189947: 54 items manufactured and released on 15-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, 28 items of the same lot have been already sold without any other similar reported event.Additional device involved batch review performed on 14 december 2020: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452)lot.188279 lot 188279: 42 items manufactured and released on 09-jan-2019.Expiration date: 2023-12-18.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
A revision surgery of the shoulder was performed on dec 7th, due to an infection 2 motnhs after primary.After a blood test, the finding of a subcutaneous abscess and intra-joint serous collection, the sepsis was found and the surgeon had to remove the shoulder lat.Glenosphere and humeral reverse hc liner.The area has been disinfected with an antiseptic povidone iodine and new implant was placed.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs department on 4 january 2021: delayed infection in reverse shoulder arthroplasty, 9 weeks after primary operation.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Additional Manufacturer Narrative
Devices returned on 12-feb-2021 and analyzed on 18-feb-2021.Visual inspection performed by r&d shoulder manager: the glenosphere does not show signs of damage.Minor negligeable scratches are present on the articular surface of the liner.Given their shape, the scratches are more likely to have occurred while removing the implant.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X27
• Common Device Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11115737
• Report Number: 3005180920-2021-00007
• Device Sequence Number: 3608438
• Product Code: PHX
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/09/2021

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: 04/30/2024
• Device Model Number: 04.01.0211
• Device Catalogue Number: 04.01.0211
• Device Lot Number: 189947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/03/2021; 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 104