MAUDE Adverse Event Report: CATALYST ORTHOSCIENCE ARCHER R1 REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS

Model Number	1230-7512-002
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants were visually inspected and found no sign of breakage or obvious defect.Scratches were found on the glenosphere, more than likely caused during implant removal.The implants were disassembled for further evaluation/investigation.The implants did not show any sign of failure and the threads were not stripped or deformed.The implants were visually and functionally within specification/good condition and deemed as acceptable product.
Event or Problem Description
Original surgery was (b)(6) 2022.First revision was (b)(6) 2023 for an instability event.Patient had a second instability event and surgeon revised again, utilizing onlay design.There was no report of a traumatic event and this was the first notification of both revision surgeries.When removing the implant, the glenosphere, glenosphere locking screw and baseplate locking cap came off in one piece.

• Brand Name: ARCHER R1 REVERSE SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): CATALYST ORTHOSCIENCE; 14710 tamiami trail n.; suite 102; naples FL 34110
• Manufacturer Contact: dale davison ; 14710 tamiami trail n.; suite 102; naples, FL ; 2393259976
• MDR Report Key: 16689179
• Report Number: 3012552981-2023-00029
• Device Sequence Number: 12281950
• Product Code: PHX
• UDI-Device Identifier: 00811596030674
• UDI-Public: (01)00811596030674(17)261117(10)2111101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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 Model Number: 1230-7512-002
• Device Catalogue Number: 1230-7512-002
• Device Lot Number: 2111101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART #1230-7512-002, LOT #2111101
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male