MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM; HUMERAL REVERSE LINER

Model Number	04.01.0125
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 july 2022: lot 2108196: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-09-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional device involved in the event, batch review performed on 07-jul-2022: reverse shoulder system 04.01.0225 long humeral diaphysis - l200 - 7 (k192967) lot.1900937.Lot 1900937: (b)(4) items manufactured and released on 19-july-2019.Expiration date: 2024-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had primary surgery of medacta products on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a loose humeral component and the cause is unknown.The surgeon revised the diaphysis, metaphysis, and liner.The surgery was completed successfully.The patient had a previous revision surgery of competitor's products: reverse 6+ years post primary that was missing a large portion of the proximal humerus.Presently, on (b)(6) 2022, the patient came in reporting pain due to a dislocation of the liner from the competitor glenosphere and stem loosening.The surgeon removed the reverse liner, metaphysis and stem and implanted an anatomic metaphysis, double eccenter and humeral head.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM
• Common Device Name: HUMERAL REVERSE LINER
• 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: 15072646
• Report Number: 3005180920-2022-00552
• Device Sequence Number: 5489466
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/21/2022

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: 09/22/2026
• Device Model Number: 04.01.0125
• Device Catalogue Number: 04.01.0125
• Device Lot Number: 2108196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2021
• 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: Female