MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5; SHOULDER LATERALIZED GLENOSPHERE

Model Number 04.01.0207

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2023.Lot 2117351: (b)(4) items manufactured and released on 22-feb-2022.Expiration date: 2027-feb-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 8 months after the primary rsa surgery due to glenosphere disassociation from the baseplate.According to report, the glenosphere screw was found intact during the revision.Three polyaxial locking screws were used during the primary surgery; during the revision surgery, the surgeon noted that the locking screws were not locked.The surgeon revised the metaphysis, liner and glenosphere.The surgery was completed successfully.The causes for disassociation cannot be determined with certainty with the elements at hand.Normally, this happens if the taper spigot of the baseplate could not engage fully the glenosphere matching taper.Among the possible reasons for such an occurrence may be a baseplate screw head protruding from the baseplate surface, and preventing the glenosphere to reach its final seating.Additional involved implant: batch review performed on (b)(6) 2023 on reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058 ) lot.2006584 lot 2006584: (b)(4) items manufactured and released on 06-nov-2020.Expiration date: 2025-oct-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

Revision surgery performed 8 months after the primary surgery due to glenosphere disassociation from baseplate (the glenosphere screw was found intact during the revision).Three polyaxial locking screws were used during the primary surgery; during the revision surgery, the surgeon noted that the locking screws were not locked.The surgeon revised the metaphysis, liner and glenosphere.The surgery was completed successfully.It is unknown if the glenosphere guide was used during the primary surgery.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
• Type of Device: SHOULDER LATERALIZED GLENOSPHERE
• 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: 16813632
• MDR Text Key: 313987551
• Report Number: 3005180920-2023-00310
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2117351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male