MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36X22; SHOULDER GLENOSPHERE

Model Number	04.01.0168
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 january 2021: lot 179965: (b)(4) items manufactured and released on 18-apr-2018.Expiration date: 2024-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by medacta shoulder r&d manager: no sign of incorrect seating is visible on the x-ray made after the primary surgery.The second x-ray shows rotation of the glenosphere with respect to the baseplate and backing of the glenosphere screw.The latest x-ray confirms that the glenosphere dissociated from the baseplate.The liner is damaged on the superior rim due to friction with the scapula and the glenoid implant.It is not clear whether the backsurface of the glenosphere has circular scratches in correspondence of the glenoid screws.A visual inspection of the explants may help determine the root cause.Visual inspection performed by medacta shoulder r&d manager: the glenosphere presents circular signs on the backsurface caused by friction with the glenoid polyaxial screws.It is not possible to determine if the screws were correctly inserted in their intended position or they backed out after the primary surgery.The outer surface of the glenosphere screw is discoloured due to friction with the inner recess of the glenosphere.The liner is damaged on the superior rim due to friction with the scapula and the glenoid implant.Clinical evaluation performed by medacta medical affairs director: dissociation of glenosphere from baseplate in primary cementless rsa after approx.1 year since operation.From the postoperative image, it appears that the glenosphere could not reach final seating on the taper spigot this may have been prevented from soft tissue interposition, or from incomplete seating of the baseplate fixation screws, although the report states that these appeared to be well inserted.The incomplete seating of the glenosphere is known to increase probability of dissociation.The root cause cannot be establish with certainty, but it seems likely that incomplete seating may have originated the dissociation event.
Event or Problem Description
Revision surgery performed after 1 year and 2 months from the primary surgery due to glenosphere screw disassociation and disassociation of the glenosphere from the baspelate.During the revision surgery, the baseplate locking screws were retightening during the revision surgery.No problems of the baseplate locking screws were reported.Glenosphere and hc liner were replaced with the new ones.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36X22
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11242689
• Report Number: 3005180920-2021-00077
• Device Sequence Number: 3842783
• Product Code: PHX
• UDI-Device Identifier: 07630040706551
• UDI-Public: 07630040706551
• 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: 2019
• Device Explanted Year: 2020
• 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): 01/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Model Number: 04.01.0168
• Device Catalogue Number: 04.01.0168
• Device Lot Number: 179965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/28/2021
• 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: 70 YR