MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had a initial left tka on (b)(6) 2010.In approximately 2016, the patient had a revision due to polymer wear and laxity.No other patient information/medical history provided.
Additional Manufacturer Narrative
Pending investigation.200-02-32 three peg patella 32mm 1769025.204-04-44 trapezoid tibial tray sz 4f/4t 1588592.204-34-04 fluted stem extension 40l x 14 mm 1662098.204-70-00 tibial stem ext.Screw 1712470.234-02-04 optetrak asy, ps cemented femoral, sz 4, 1628337.
Additional Manufacturer Narrative
H6.Investigation results - the revision reported may have been the result of polyethylene wear and instability as stated in the operative notes.The extent and root cause of the reported polyethylene wear cannot be determined as the devices were not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.These devices are used for treatments, not diagnosis.There is no other information available.
Event or Problem Description
As reported, the patient had a initial left tka.The patient had a revision due to polymer wear and laxity.No other patient information/medical history provided.No device returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3 (remove date - unknown), d6b (remove date - unknown), f10 (remove data from initial), g1, g2, h6: clinical code, medical device problem code, component code, investigation findings.D6b: patient has been revised.Date is unknown at this time.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 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15414718
• Report Number: 1038671-2022-01104
• Device Sequence Number: 6744846
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 07/08/2016
• Device Model Number: PS TIBIAL INSERTS SZ 4, 13MM
• Device Catalogue Number: 204-24-13
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 02/23/2024; 02/02/2026
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 03/14/2024; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2008
• 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 Sex: Male