MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-09
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 14 years post op initial right tka, this 83 y/o female patient was revised.Knee was unstable, surgeon did a poly exchange of old optetrak.Patient was last known to be in stable condition following the event.Unknown medical history.X-ray was provided as well as a picture of her operative report from 2009.Product not being returned due to the account would not return the product due to their guidelines.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 200-02-32 - three peg patella 32mm 1416422 204-01-02 - ps cemented femoral sz 2 8101073 204-04-23 - trapezoid tibial tray sz 1f/3t, 2f/3t 1306396 204-32-01 - fluted stem extension 11l x 12 mm 1180531 620-00-02 - platelet rich plasma kit with spray tips 101311 620-11-02 - accelerate conc.Sys rep by 620-12-02 6001290901.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the reported revision due to instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Instability is a known risks, as outlined in the ifu.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, 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17297215
• Report Number: 1038671-2023-01600
• Device Sequence Number: 19802053
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 01/29/2017
• Device Catalogue Number: 204-22-09
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2009
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 83 YR
• Patient Sex: Female