MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27; SHOULDER GLENOSPHERE

Catalog Number	04.01.0172
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2023 lot 179112: 115 items manufactured and released on 26-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, 101 items of the same lot have been sold with no similar reported event during the period of review.Analysis performed by r&d manager: the presence of ring marks on the glenosphere backsurface and the damage on the screw heads suggest a contact between the involved components.It is not possible to determine whether the screws were positioned proud from the baseplate during the surgery or the screws backed off leading to contact between the screws and the glenosphere.No action is suggested.Other components involved: reverse shoulder system 04.01.0156 glenoid baseplate ø27x35 (k170452) lot 183534: 50 items manufactured and released on 25-jul-2018.Expiration date: 2023-07-17.No anomalies found related to the problem.To date, 22 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 1811899: 150 items manufactured and released on 21-mar-2019.Expiration date: 2024-03-09.No anomalies found related to the problem.To date, 143 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 1811900: 160 items manufactured and released on 21-mar-2019.Expiration date: 2024-03-09.No anomalies found related to the problem.To date, 152 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 1811901: 250 items manufactured and released on 21-mar-2019.Expiration date: 2024-03-09.No anomalies found related to the problem.To date, 246 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 182474: 378 items manufactured and released on 07-sept-2018.Expiration date: 2023-08-28.No anomalies found related to the problem.To date, 363 items of the same lot have been sold with no similar reported event during the period of review.Only 2 of the 4 screws implanted were damaged but it was not possible to know which ones.The batch review of all screws have been included.
Event or Problem Description
At 3 years and 5 months from the primary, the patient came in reporting pain and a limited range of motion due to dissociation of the glenosphere from the baseplate.The cause of the dissociation is unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.There are screw ring marks on the back side of the glenosphere, and two polyaxial screw heads were also found to be damaged.A mild degree of metallosis was also observed.
Additional Manufacturer Narrative
On 12-december-2023 we have received the implants visual inspection performed by r&d project manager: mild circumferential signs are visible on the convex backsurface of the glenosphere due to friction with at least one peripheral glenoid screw.It is not possible to state whether the screw was positioned proud form the baseplate after the primary surgery or it backed out in the following months.The glenosphere screw shows circular scratches on the outer surface.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18272871
• Report Number: 3005180920-2023-00959
• Device Sequence Number: 12685535
• Product Code: PHX
• UDI-Device Identifier: 07630040706599
• UDI-Public: 07630040706599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: 03/14/2023
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 179112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2018
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian