MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30; REVERSE SHOULDER GLENOID

Model Number 04.01.0191

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 october.2021.Lot 1904749: (b)(4) items manufactured and released on 4-dec-2019.Expiration date: 2024-nov-24.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Additional components involved.Reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot.2103688.Lot 2103688: (b)(4) items manufactured and released on 4-dec-2019.Expiration date: 2024-nov-24.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot.2103783.Lot 2103783: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-may-06.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events (2 pieces of this lot reported in this complaint).Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot.2010016.Lot 2010016: (b)(4) items manufactured and released on 27-nov-2020.Expiration date: 2025-nov-18.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot.2006965.Lot 2006965: (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-aug-19.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0007 std humeral diaphysis - cementless - 12 (k170452) lot.2006061.Lot 2006061: (b)(4) items manufactured and released on 20-oct-2020.Expiration date: 2025-oct-08.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003795.Lot 2003795: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-nov-26.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot.189839 lot 189839: (b)(4) items manufactured and released on 25-jan-2019.Expiration date: 2024-jan-13.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.

Event Description

The patient had a primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting instability and looseness and the cause was unknown.The surgeon revised the liner and metaphysis.The surgery was completed successfully.Complaint (b)(4) was filed.Subsequently, on (b)(6) 2021, the patient came in due to a dislocation of the humerus from the glenosphere.The surgeon revised the baseplate, lateralized glenosphere, humeral diaphysis, reverse metaphysis, and liner.The surgery was completed successfully.Complaint (b)(4) was filed.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Type of Device: REVERSE 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: 12779042
• MDR Text Key: 280568717
• Report Number: 3005180920-2021-00867
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 04.01.0191
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 1904749
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male