MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM; SHOULDER REVERSE LINER PE

Model Number	04.01.0124
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 july 2022: lot 175050: (b)(4) items manufactured and released on 27-sept-2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component involved: reverse shoulder system 04.01.0173 glenosphere 39xø27 (k170452) lot.2115427: (b)(4) items manufactured and released on 22-feb-2022.Expiration date: 2027-02-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 1 month and a half from primary surgery, the surgeon performed a washout and revised the liner and glenosphere.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• Common Device Name: SHOULDER REVERSE LINER PE
• 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: 15199312
• Report Number: 3005180920-2022-00604
• Device Sequence Number: 17702864
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/10/2022

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: 09/07/2022
• Device Model Number: 04.01.0124
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 175050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2017
• 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