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

Model Number	1230-7504-002
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned poly insert was evaluated and found nicked, deformed and scratched.There are two factors that could contribute to the condition.One factor is not following the surgical technique and not assembling the poly insert completely into the stem.The other factor is the poly insert experiencing high force not in-line with the insert/stem interface.
Event or Problem Description
The poly insert was implanted on (b)(6) 2022.The patient reported a traumatic fall and a revision surgery on (b)(6) 2023 was performed and noted the poly had dissociated from the humeral stem.

• 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: 17069986
• Report Number: 3012552981-2023-00058
• Device Sequence Number: 6775603
• Product Code: PHX
• UDI-Device Identifier: 00811596030452
• UDI-Public: (01)00811596030452(17)270708(10)211071
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: 1230-7504-002
• Device Catalogue Number: 1230-7504-002
• Device Lot Number: 211071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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: 1230-7504-002, LOT #211071.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male