MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0174
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24.Feb.2021.Lot 189747: (b)(4) items manufactured and released on 12-mar-2019.Expiration date: 2024-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0156 glenoid baseplate ø27x35 (k170452) lot.179103.Batch review performed on 12.Mar.2021: lot 179103: (b)(4) items manufactured and released on 18-apr-2018.Expiration date: 2023-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: reverse shoulder system 04.01.0126 humeral reverse hc liner ø42/+3mm (k170452) lot.179983.Batch review performed on 24.Feb.2021: lot 179983: (b)(4) items manufactured and released on 22-apr-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event due to infection.Additional implant involved: reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot.179107.Batch review performed on 12.March.2021: lot 179107: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Additional implant involved: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot.174748.Batch review performed on 12.March.2021: 174748: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported events.Additional implant involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.1901907.Batch review performed on 12.March.2021: lot 1901907: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: revision of rsa after 1.5 years due to infection.At revision, the glenosphere is found to have detached from the baseplate, and the surgeon reportedly suspects that one of the baseplate screws, not fully inserted, may have prevented the glenosphere from reaching the final seat and achieving correct locking.The radiographs supplied do not add any useful information to the determination of these circumstances.
Event or Problem Description
Revision surgery performed 1 year and 4 months after the primary surgery due to infection(sepsis) and disassociation of the glenosphere from the baseplate.Metallosis and liner deformation was visible during the surgery.Glenosphere, glenoid polyaxial locking screw and liner were removed.Re-locking the glenoid polyaxial locking screw to be certain it was locked.Previously this patient had competitor implants implanted, but the reason of its removal and implantation of medacta implants is unknown.
Additional Manufacturer Narrative
On april 26th 2021 the device has been received.Visual inspection performed by r&d shoulder manager: circumferential signs are visible on the convex back surface of the glenosphere, probably due to friction with a peripheral glenoid screw.It is not possible to state whether the screw was positioned proudly from the baseplate after the primary surgery or it backed out in the following months.The glenosphere screw shows circular scratches on the outer surface.The outer rim of the liner is massively damaged.This is presumed to have occurred following friction with the scapula after the glenosphere dissociation.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11471403
• Report Number: 3005180920-2021-00197
• Device Sequence Number: 3679003
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 05/26/2021

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: 03/02/2024
• Device Model Number: 04.01.0174
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 189747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: 71 YR