MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-23-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Fibrosis (3167); Joint Laxity (4526)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2009.Approximately 9 years and 3 months after the initial procedure the patient had a right knee revision on (b)(6) 2019.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2019 diagnosis: failed right knee fluid was clear.There was significant synovitis due to osteolysis and particle disease.The polyethylene was removed.Tibial component was loose and removed.The patient was awakened and transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: 1513137 234-03-03 - optetrak asy,ps cemented femoral, sz 3, 1522795 200-02-29 - three peg patella 29mm 1553085 200-04-33 - cemented finned tib.Tra sz 3f/3t pending investigation.
Additional Manufacturer Narrative
1038671-2024-04967 multiple mdr reports were filed for this event, please see associated report: 1038671-2024-04967.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, medical device problem code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and instability.Or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 3, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18450065
• Report Number: 1038671-2024-00021
• Device Sequence Number: 7632991
• Product Code: JWH
• UDI-Device Identifier: 10885862048325
• UDI-Public: 10885862048325
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 02/24/2017
• Device Catalogue Number: 204-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0020-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 99 KG