MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

Model Number	04.01.0173
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 january 2022: lot 1909882: 69 items manufactured and released on 26-mar-2020.Expiration date: 2025-mar-16.No anomalies found related to the problem.To date, 66 items of the same lot have been sold with no similar reported event.Preliminary investigation performed by r&d manager: the x-ray at the 6-week follow-up confirms that the glenosphere screw got loose and exited from the glenosphere recess.The explanted glenosphere shows circular black markings on the backsurface due to friction with at least one protruding glenoid screw.It is not possible to determine whether the glenoid screws were fully seated during the primary surgery or they backed-out in the early post-operative time.No action is suggested.Clinical evaluation performed by medical affairs director: 1,5 years after primary rsa the glenosphere fixation screw is found to have backed out significantly.It should be expected that the fixation of the glenosphere has lost strength, although no revision surgery has been carried out yet.Rather often, the cause for such a situation is incomplete seating of one or more of the baseplate fixation screws, for whatever reason, but this cannot be verified until revision surgery is performed.To date, therefore, we cannot formulate a reasonable hypothesis on the most likely root cause for this situation.
Event or Problem Description
Revision surgery will be performed about 1 years and 7 months after the primary surgery due to glenosphere screw loosening.
Event or Problem Description
Revision surgery will be performed about 1 years and 7 months after the primary surgery due to glenosphere screw loosening.
Additional Manufacturer Narrative
Batch review performed on 13 january 2022: lot 1909882: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-mar-16.No anomalies found related to the problem.To date, 66 items of the same lot have been sold with no similar reported event.Preliminary investigation performed by r&d manager: the x-ray at the 6-week follow-up confirms that the glenosphere screw got loose and exited from the glenosphere recess.The explanted glenosphere shows circular black markings on the backsurface due to friction with at least one protruding glenoid screw.It is not possible to determine whether the glenoid screws were fully seated during the primary surgery or they backed-out in the early post-operative time.No action is suggested.Clinical evaluation performed by medical affairs director: 1,5 years after primary rsa the glenosphere fixation screw is found to have backed out significantly.It should be expected that the fixation of the glenosphere has lost strength, although no revision surgery has been carried out yet.Rather often, the cause for such a situation is incomplete seating of one or more of the baseplate fixation screws, for whatever reason, but this cannot be verified until revision surgery is performed.To date, therefore, we cannot formulate a reasonable hypothesis on the most likely root cause for this situation.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
• Common Device Name: 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: 13498302
• Report Number: 3005180920-2022-00073
• Device Sequence Number: 4252605
• 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: 2020
• Device Explanted Year: 2022
• 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): 02/09/2022

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: 03/16/2025
• Device Model Number: 04.01.0173
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 1909882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2020
• 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 Age: 82 YR
• Patient Sex: Male