MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM

Model Number	04.01.0121
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-dec-2020: lot 2000923: (b)(4) items manufactured and released on 05-may-2020.Expiration date: 19-apr-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved: batch review performed on 28-dec-2020: reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175)lot.2003791 : lot 2003791: (b)(4) items manufactured and released on 08-sep-2020.Expiration date: 02-sep-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed on (b)(6) 2020 due to recurrent shoulder dislocation (glenosphere and inlay have been revised) 3 months after the primary surgery((b)(6) 2020).The patient was already revised, at the beginning of (b)(6) 2020, where the inlay has been changed from ø36/+0mm to ø36/+6mm.
Additional Manufacturer Narrative
Devices returned on 27-jan-2021 and analyzed.Visual inspection performed by r&d project manager.The visual inspection was performed on wednesday, 27th january 2021.The articular surface of the liner has scractches, probably caused during the removal of the implant.The articular suface of the glenosphere is partially dull, probably due to contact with the reverse metaphysis.The glenosphere screw is partially discoloured due to friction with the inner recess glenosphere.The explants included the "reverse metaphysis screw".

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+6MM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11116243
• Report Number: 3005180920-2021-00008
• Device Sequence Number: 14354561
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/26/2021

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: 04/19/2025
• Device Model Number: 04.01.0121
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 2000923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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
• Patient Age: 69 YR
• Patient Weight: 80