MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48; ANATOMICAL GLENOID COMPONENT

Model Number	04.01.0132
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2021: lot 181490: (b)(4) items manufactured and released on 13-giu-2018.Expiration date: 2023-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: anatomical shoulder system 04.01.0094 metal humeral head ø48 (k170910) lot.1710140.Batch review performed on 03 march 2021: lot 1710140: (b)(4) items manufactured and released on 14-ago-2017.Expiration date: 2022-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The surgeon planned to revise the patient shoulder for a dislocation (head from liner) on (b)(6) 2021.The primary surgery date is not available.
Event or Problem Description
The surgeon revised the patient's shoulder implants for a dislocation (head from liner) on (b)(6) 2021.The primary surgery date is not available.The shoulder has been dislocated for 4 months.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48
• Common Device Name: ANATOMICAL GLENOID COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11494442
• Report Number: 3005180920-2021-00216
• Device Sequence Number: 5349248
• Product Code: KWS
• UDI-Device Identifier: 07630040713276
• UDI-Public: 07630040713276
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 05/06/2021

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: 06/03/2023
• Device Model Number: 04.01.0132
• Device Catalogue Number: 04.01.0132
• Device Lot Number: 181490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: Other; Required Intervention