MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30; GLENOID POLYAXIAL SCREW

Model Number	04.01.0161
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2103988: 240 items manufactured and released on 27-may-2021.Expiration date: 2026-05-10.No anomalies found related to the problem.To date, 217 items of the same lot have been sold with no similar reported case during the period of the review.Additional device involved.Batch reviews performed on 20-jul-2023: reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2118705: 89 items manufactured and released on 14-feb-2022.Expiration date: 2027-01-27.No anomalies found related to the problem.To date, 87 items of the same lot have been sold with no similar reported case during the period of review.Reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 2113523: 70 items manufactured and released on 14-feb-2022.Expiration date: 2027-01-27.No anomalies found related to the problem.To date, 61 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager on (b)(6) 2023: revision 1 year and 1 month after the primary rsa, due to a loose glenosphere and baseplate.As it is visible in the radiographic image, the most superior screw is broken.For unknown reasons the baseplate was not able to integrate and it may be possible that there was not primary stability.Therefore, in these conditions the screw could not indefinitely support the implants and it broke.It may be possible that due to the loosening an impingment between the humerus implant and the glenosphere might have happened.
Event or Problem Description
At about 1 year and 1 month after the primary, the patient came in reporting pain due to a loose baseplate, which had also not integrated with the bone.Upon opening the patient, it was also noted that one of the two l30 screw had broken (it is unknown which one broke).The surgeon revised successfully all components with competitor components.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
• Common Device Name: GLENOID POLYAXIAL SCREW
• 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: 17368998
• Report Number: 3005180920-2023-00535
• Device Sequence Number: 17894837
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/21/2023

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: 05/10/2026
• Device Model Number: 04.01.0161
• Device Catalogue Number: 04.01.0161
• Device Lot Number: 2103988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2021
• 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