MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	PS TIBIAL INSERTS SZ 2, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Aseptic loosening (4883)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6).234-03-02 - optetrak asy,ps cemented femoral, sz 2, (b)(6).200-02-35 - three peg patella 35mm, (b)(6).204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2011.Approximately 6 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2018.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) 2018 diagnosis: aseptic loosening of the tibia with large metaphyseal uncontained bony defect and polyethylene wear.There was a gross amount of synovitis and synovium where i had to do a subtotal synovectomy both superiorly and into the medial and lateral gutters.The surgeon did a standard medial peel and took out a significant amount of synovitis laterally and underneath the patella tendon to get the patella everted.The tibial component was grossly loose.The patient was taken to the pacu in stable condition.
Additional Manufacturer Narrative
H10.Updated/additional information ¿ the revision reported may have been the result of polyethylene wear and aseptic loosening as stated in the operative notes.The aseptic (non-infected) tibial loosening may have been the result of both patient-related conditions and insufficient bonds between the tibial tray and the bone.The extent and root cause of the polyethylene wear cannot be determined as the explanted devices were not returned for evaluation, and radiographs / photographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, e1-4, g2 (correcting initial report), h6: clinical codes, medical device problem codes, component code, types of investigation and investigation conclusion.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 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17546354
• Report Number: 1038671-2023-01941
• Device Sequence Number: 6430461
• Product Code: JWH
• UDI-Device Identifier: 10885862048233
• UDI-Public: 10885862048233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2018
• Device Model Number: PS TIBIAL INSERTS SZ 2, 11MM
• Device Catalogue Number: 204-22-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 04/23/2024; 01/22/2026
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 04/29/2024; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2010
• 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-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female