MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27; SHOULDER GLENOSPHERE

Model Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon revised the glenosphere and the liner 2 years and 3 months after primary following glenosphere screw loosening.The glenosphere was completely mobile, but not displaced.The screw was completely loose also, but still in the glenosphere.
Additional Manufacturer Narrative
Batch review performed on 25 january 2022.Lot 183804: (b)(4) items manufactured and released on 03-jan-2019.Expiration date: 2023-12-13.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.Clinical evaluation performed by medical affairs director: two years after primary rsa, the central screw supposed to fix the glenosphere to the baseplate is found to have partially backed out at standard radiographic analysis.The glenosphere is not displaced and the screw is still in its original seat, but displacement due to self-unscrewing is deemed to be imminent and therefore revision surgery is undertaken.There is no information on the possibility that the baseplate screws were found to have backed out, or to be protruding from the baseplate: this could be a cause for the self-unscrewing of the central screw, that may never have reached the final position.No other cause for self-unscrewing could be identified so far.Visual inspection performed by (b)(4) shoulder manager: the immediate post-op x-rays show inferior orientation of the glenosphere eccentricity, while in the x-rays taken at the 6-week follow-up the glenosphere is oriented in the proximal direction and the glenosphere screw looks still in its intended position.At 2-year follow-up the glenosphere screw is not engaged anymore in the baseplate threaded hole.Mild circumferential signs are visible on the convex backsurface of the glenosphere, probably due to friction with at least one peripheral glenoid screw.The glenosphere screw shows circular scratches on the outer surface.No action is suggested.Additional items involved in the event, batch review performed on 25 january 2022: external supplier analysis: reverse shoulder system 04.01.0155 glenoid baseplate ø27x25 (k170452) lot.1811000 lot 1811000: (b)(4) items manufactured and released on 21-feb-2019.Expiration date: 2024-02-11.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.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13557274
• Report Number: 3005180920-2022-00119
• Device Sequence Number: 17065039
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 12/13/2023
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 183804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2019
• 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: Unknown