MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 4, 9MM, VIT E; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	PS TIBIAL BEARING, SIZE 4, 9MM, VIT E
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Visual evaluation found no problems with the color or shape of the device.No problem found.
Event or Problem Description
On 9/29/2022, it was reported by a sales representative via email that an ar-523-b409 ps tibial bearing back side was round.Surgeon attempted to impact the poly in, without any success, as the surgeon could easily lift it out.The poly would not snap in.Another poly was opened and both were examined prior to implantation.That is when surgeon noticed the difference in appearance.The new poly was used to complete the case without further issues.This was discovered during a total knee procedure on (b)(6) 2022.Additional information received 10/3/2022: nothing broke inside the patient and case was completed with another ar-523-b409 ps tibial bearing from lot number 5791824.

• Brand Name: PS TIBIAL BEARING, SIZE 4, 9MM, VIT E
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19154272
• Report Number: 1220246-2024-02211
• Device Sequence Number: 7335533
• Product Code: MBH
• UDI-Device Identifier: 00888867232457
• UDI-Public: 00888867232457
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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 Expiration Date: 07/31/2024
• Device Model Number: PS TIBIAL BEARING, SIZE 4, 9MM, VIT E
• Device Catalogue Number: AR-523-B409
• Device Lot Number: 5791932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown