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

Model Number	1230-7513-002
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants were visually inspected and found the center hole threads of the augmented baseplate deformed and stripped.However, the locking cap did not have stripped threads or any deformation, as seen in the baseplate.The peripheral holes of the baseplate also had some cross threading, as intended per design.The screws were visually inspected and three were found to be in normal condition.Two screws displayed visual signs of stripping at the head, normally caused by overtightening of the small driver.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.The locations of failure are the central threads of the augmented baseplate and the taper connection between the glenosphere and baseplate.This is not likely to have been caused by a defective implant, as the locking cap was in acceptable condition.Under normal conditions and use, the augmented baseplate would not see this type of deformation and if so, the locking cap would display a visual nonconformance.It is likely that dissociation of the baseplate would not have occurred without a significant traumatic event or loading incident.Therefore, it is believed that the glenosphere was not properly inserted onto the baseplate.
Event or Problem Description
Initial surgery was performed on (b)(6) 2022 using catalyst implants for the glenoid side and a lima stem on the humeral side.In (b)(6) 2023, the patient reported stability issues.Upon further examination, the glenosphere had dissociated from the baseplate.The patient did not report a traumatic event.Revision surgery was performed on (b)(6) 2023, the glenosphere implant size 36 lat and baseplate were removed and replaced with the same type/size of construct with no further issues identified.
Event or Problem Description
Initial surgery was performed on (b)(6) 2022 using catalyst implants for the glenoid side and a lima stem on the humeral side.In february 2023, the patient reported stability issues.Upon further examination, the glenosphere had dissociated from the baseplate.The patient did not report a traumatic event.Revision surgery was performed on (b)(6) 2023, the glenosphere implant size 36 lat and baseplate were removed and replaced with the same type/size of construct with no further issues identified.
Additional Manufacturer Narrative
The returned implants were visually inspected and found the center hole threads of the augmented baseplate deformed and stripped.However, the locking cap did not have stripped threads or any deformation, as seen in the baseplate.The peripheral holes of the baseplate also had some cross threading, as intended per design.The screws were visually inspected and three were found to be in normal condition.Two screws displayed visual signs of stripping at the head, normally caused by overtightening of the small driver.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.The locations of failure are the central threads of the augmented baseplate and the taper connection between the glenosphere and baseplate.This is not likely to have been caused by a defective implant, as the locking cap was in acceptable condition.Under normal conditions and use, the augmented baseplate would not see this type of deformation and if so, the locking cap would display a visual nonconformance.It is likely that dissociation of the baseplate would not have occurred without a significant traumatic event or loading incident.Therefore, it is believed that the glenosphere was not properly inserted onto the baseplate.

• 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 34110 ; 2393259976
• MDR Report Key: 16567294
• Report Number: 3012552981-2023-00018
• Device Sequence Number: 12137003
• Product Code: PHX
• UDI-Device Identifier: 00811596030698
• UDI-Public: (01)00811596030698(17)270104(1)2111102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202611
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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
• Device Model Number: 1230-7513-002
• Device Catalogue Number: 1230-7513-002
• Device Lot Number: 2111102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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 #1230-7513-002, LOT #2111102; PART #1230-7513-002, LOT #2111102
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown