MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 42; ANATOMICAL SHOULDER HC PEGGED GLENOID

Model Number	04.01.0129
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 october 2020 lot 182673: 66 items manufactured and released on 16-aug-2018.Expiration date: 2023-07-29.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold without any similar reported event.Additional items involved in the event, batch review performed on 05 october 2020 anatomical shoulder system 04.01.0092 metal humeral head ø44 (k170910) lot.1710136 lot 1710136: 53 items manufactured and released on 24-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, 40 items of the same lot have been already sold without any similar reported event.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot.189741 lot 189741: 101 items manufactured and released on 13-mar-2019.Expiration date: 2024-03-03.No anomalies found related to the problem.To date, 94 items of the same lot have been already sold without any similar reported event.Anatomical shoulder system 04.01.0025 humeral anatomical metaphysis - cementless - 135° - 8 (k170910) lot.1710036 lot 1710036: 80 items manufactured and released on 25-may-2018.Expiration date: 2023-05-13.No anomalies found related to the problem.To date, 40 items of the same lot have been already sold without any similar reported event.Anatomical shoulder system 04.01.0003 std humeral diaphysis - cementless - 8 (k170452) lot.176936 lot 176936: 80 items manufactured and released on 30-nov-2017.Expiration date: 2022-11-09.No anomalies found related to the problem.To date, 66 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 1 year and 3 months after primary surgery, reporting pain and the cause of the pain is unknown.The surgeon revised all anatomic components to reverse components.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 42
• Common Device Name: ANATOMICAL SHOULDER HC PEGGED GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10718019
• Report Number: 3005180920-2020-00731
• Device Sequence Number: 3111792
• Product Code: KWS
• UDI-Device Identifier: 07630040713245
• UDI-Public: 07630040713245
• Combination Product (Y/N): N
• 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: 2020
• 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): 10/22/2020

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: 07/29/2023
• Device Model Number: 04.01.0129
• Device Catalogue Number: 04.01.0129
• Device Lot Number: 182673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/22/2020
• 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