MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 6, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	204-26-11
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Osteolysis (2377); Implant Pain (4561)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient is experiencing severe pain, inflammation, and osteolysis, among other things due to the optetrak total knee replacement.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 201-78-15 - holding pin mini sharp point 4 pk 1387234, 201-78-81 - 3" trocar, mod.Hex 2pk 1032806, 203-96-03 - (11-2216) saw blade new stryker (.050) 85097, 203-96-10 - (11-2325) stryker 2000 90x13mm.050" 1.27mm 83319, 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm 89080, 204-01-06 - ps cemented femoral sz 6 0783532, 204-04-65 - trapezoid tibial tray sz 6f/5t 0976357, 204-32-01 - fluted stem extension 11l x 12 mm 1377032, 204-70-00 - tibial stem ext.Screw 1388145,.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The implant is approximately 13 years old.The cause of the pain, inflammation, and osteolysis cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported via legal that this male patient is experiencing severe right knee pain, inflammation, and osteolysis, "among other things due to the optetrak total knee replacement".Implanted on or about (b)(6), 2009, there is no indication or mention of revision surgery.No additional information was provided.
Event or Problem Description
It was reported via legal that this male patient is experiencing severe right knee pain, inflammation, and osteolysis, "among other things due to the optetrak total knee replacement".Implanted on or about (b)(6), 2009, there is no indication or mention of revision surgery.No additional information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, e1,-3 (initial report), g2 (initial report), h6: clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The implant is approximately 13 years old.The cause of the pain, inflammation, and osteolysis cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.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 6, 11MM
• 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: 15502083
• Report Number: 1038671-2022-01191
• Device Sequence Number: 7848965
• Product Code: JWH
• UDI-Device Identifier: 10885862048547
• UDI-Public: 10885862048547
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2009
• Device Model Number: 204-26-11
• Device Catalogue Number: 204-26-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 12/16/2025
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2004
• 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: Other; Required Intervention
• Patient Sex: Male