MAUDE Adverse Event Report: CATALYST ORTHOSCIENCE ARCHER R1 REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS, PRODUCT CODE: PHX

Model Number	1230-7504-003
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
Event or Problem Description
Original surgery was completed on (b)(6) 2021.The patient ignored guidelines provided by surgeon and was playing full-contact ice hockey, where he was checked and landed on his shoulder.Revision surgery was completed on (b)(6) 2023 where poly insert implant size 36 +8 was removed and upsized to a semi-constrained poly insert implant size 36 +0 and humeral spacer implant +12.

• Brand Name: ARCHER R1 REVERSE SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS, PRODUCT CODE: PHX
• 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: 16400577
• Report Number: 3012552981-2023-00015
• Device Sequence Number: 5592843
• Product Code: PHX
• UDI-Device Identifier: 00811596030469
• UDI-Public: (01)00811596030469(17)260802(10)2105615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/17/2023

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 Expiration Date: 08/02/2026
• Device Model Number: 1230-7504-003
• Device Catalogue Number: 1230-7504-003
• Device Lot Number: 2105615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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: 1230-7504-003, LOT #2105615
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male