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

Model Number	1230-7505-003
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: poly insert implant size 40 +8, 1230-7505-003, lot # 2105624.The revision surgery was completed as intended.The investigation is ongoing.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Hold for kp 3.10 it was reported that the patient underwent initial shoulder arthroplasty and approximately 02 months later was revised due to dissociation of the humeral insert from the humeral stem.The previous humeral insert and humeral stem were replaced with a new insert and stem.The patient did not report any specific event that may have caused the dissociation of the insert.Attempts to obtain further information have been made and no further information has been provided.Customer has indicated that the implants will not be returned for investigation as the implants were discarded by the hospital.

• Brand Name: ARCHER R1 REVERSE SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): CATALYST ORTHOSCIENCE INC; 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: 13722506
• Report Number: 3012552981-2022-00004
• Device Sequence Number: 20011165
• Product Code: PHX
• UDI-Device Identifier: 00811596030506
• UDI-Public: (01)00811596030506(17)260825(10)2105624
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2022
• 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): 02/24/2022

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 Expiration Date: 08/25/2026
• Device Model Number: 1230-7505-003
• Device Catalogue Number: 1230-7505-003
• Device Lot Number: 2105624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: 1230-7505-003, LOT # 2105624
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown