MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 9; CEMENTLESS HUMERAL DIAPHYSIS

Model Number	04.01.0004
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2020 lot 1907743: 37 items manufactured and released on (b)(6) 2019.Expiration date: 2024-10-13.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event.Clinical evaluation few weeks after primary rsa dislocation occurs and a new surgery with repositioning is required.A reduction of retroversion is called for and substitution of the stem is carried out.The cause for this adverse event is not to be sought in a defective device.Other devices involved in the event reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm lot.2001995 (k170452) batch review performed on 27 november 2020 lot 2001995: 75 items manufactured and released on 24-apr-2020.Expiration date: 2025-04-05.No anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 lot.189937 (k193175) batch review performed on 27 november 2020 lot 189937: 55 items manufactured and released on 9-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed 2 months after the primary surgery due to implant dislocation (liner form glenosphere).The dislocation occurred due to the stem retroversion (25-30 degrees over the desired position) and oversizing of the stem.The stem, metaphysis, inlay and glenosphere were revised successfully.

• Brand Name: REVERSE SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 9
• Common Device Name: CEMENTLESS HUMERAL DIAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11019536
• Report Number: 3005180920-2020-00893
• Device Sequence Number: 14408702
• Product Code: PHX
• UDI-Device Identifier: 07630040706032
• UDI-Public: 07630040706032
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2024
• Device Model Number: 04.01.0004
• Device Catalogue Number: 04.01.0004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/16/2020
• 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
• Patient Age: 73 YR