MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5; REVERSE GLENOSPHERE

Model Number	04.01.0170
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2021: lot 1908173: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-01-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by medacta r&d department: the x-ray confirms the glenosphere dissociation and backing of the securing screw.The spherical backsurface of the glenosphere appears to carry a circular black marking, potentially due to friction with either a peripheral screw or the baseplate edge.A visual inspection is required to better analyse shape and position of the marking and proceed with the root cause investigation.Clinical evaluation: 1.5 years after rsa the glenosphere locking screw backed out and the glenosphere got loose from the baseplate , which appears to be perfectly anchored to the bone.The reasons for the self-unscrewing of the locking screw cannot be determined with the information at hand.The absence of a post-primary xray does not allow to judge the full seating of the glenosphere at the index surgery.No conclusion can be reached to date on the root cause of this adverse event.
Event or Problem Description
Revision surgery 1 year and 5 months after primary due to intra-prosthetic dislocation of the glenosphre from the baseplate.The screw was loose but it was not out of the glenosphere.During the revision the base plate was 100% tight and both screws were fully countersunk and not looking out either.The surgeon inserted a new glenosphere.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5
• Common Device Name: REVERSE GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12538971
• Report Number: 3005180920-2021-00773
• Device Sequence Number: 11787926
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 09/28/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2025
• Device Model Number: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 1908173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/28/2021
• 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