MAUDE Adverse Event Report: CATALYST ORTHOSCIENCE CATALYST EA SHOULDER SYSTEM; SHOULDER PROSTHESIS

Model Number	1231-7602-001
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the final implant positioning sat higher than the trial implant construct.The sterile package was verified to ensure an offset adapter +0 was the device being implanted.A post-operative x-ray confirmed this difference in positioning, noting that the x-ray appeared to show an offset adapter +3 and not the offset adapter +0 as the packaged label indicated.
Additional Manufacturer Narrative
The reported event of an offset adapter +3 within an offset adapter +0 package was confirmed.A device inspection was not possible since the affected device was not returned; however, all remaining inventory was inspected.The offset adapter +3 was left inside the patient as the surgeon did not feel the joint was over tensioned.

• Brand Name: CATALYST EA SHOULDER SYSTEM
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): CATALYST ORTHOSCIENCE; 14710 tamiami trail n.; suite 102; naples 34110
• Manufacturer Contact: dale davison ; 14710 tamiami trail n.; suite 102; naples, FL 34110 ; 2393259976
• MDR Report Key: 17855379
• Report Number: 3012552981-2023-00113
• Device Sequence Number: 19680602
• Product Code: KWS
• UDI-Device Identifier: 00811596031770
• UDI-Public: (01)00811596031770(17)20280329(10)2116901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1231-7602-001
• Device Catalogue Number: 1231-7602-001
• Device Lot Number: 2116901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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 #1231-7601-001, LOT #2116901
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female