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

Model Number	04.01.0132
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02.Sept.2021: lot 1901917: (b)(4) items manufactured and released on 18-june-2019.Expiration date: 2024-june-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.Additional devices involved in the event: anatomical shoulder system 04.01.0182 short humeral diaphysis - cementless - 9 (k180089) lot.1907753.Lot 1907753: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-oct-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Anatomical shoulder system 04.01.0026 humeral anatomical metaphysis - cementless - 135° - 9 (k170910) lot.1905776.Lot 1905776: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-nov-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Anatomical shoulder system 04.01.0094 metal humeral head ø48 (k170910) lot.1811915.Lot 1811915: (b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-apr-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot.2001146.Lot 2001146: (b)(4) items manufactured and released on 07-jul-2020.Expiration date: 2025-jun-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.
Event or Problem Description
8 months after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48
• Common Device Name: SHOULDER GLENOID
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12506482
• Report Number: 3005180920-2021-00759
• Device Sequence Number: 3598174
• 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: 2020
• Device Explanted Year: 2021
• 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): 09/21/2021

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: 06/02/2024
• Device Model Number: 04.01.0132
• Device Catalogue Number: 04.01.0132
• Device Lot Number: 1901917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/21/2021
• 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