MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48; ANATOMICAL SHOULDER GLENOID

Model Number	04.01.0132
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 march 2022: lot 182676: (b)(4) items manufactured and released on 04-sept-2018.Expiration date: 2023-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At abut 2 years and 9 months after primary surgery the surgeon revised the patient shoulder for glenoid implant loosening.The surgery was completed successfully, all devices swapped.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID Ø48
• Common Device Name: ANATOMICAL SHOULDER GLENOID
• 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: 13964412
• Report Number: 3005180920-2022-00219
• Device Sequence Number: 19877985
• Product Code: KWS
• UDI-Device Identifier: 07630040713276
• UDI-Public: 07630040713276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 03/31/2022

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: 08/20/2023
• Device Model Number: 04.01.0132
• Device Catalogue Number: 04.01.0132
• Device Lot Number: 182676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2018
• 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