MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	208-22-18
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 71 y/o female patient had a right knee replacement on 4 apr 2008.Approximately 15 years after the initial procedure the patient had a right knee revision on (b)(6)2023.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)2023 preliminary diagnosis: right failed total knee arthroplasty postoperative diagnosis: right failed total knee arthroplasty imaging was consistent with failed right knee arthroplasty.A thorough synovectomy was performed.The patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6.Investigation results- the cc tibial insert with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s right failed total knee arthroplasty and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the the significant post-traumatic deformity, interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
Additional information from operative report-the patient was revised to competitor's devices.Using a combination of a small saw and osteotomes, the femoral implant was removed with minimal bone loss.The tibia was removed with minimal bone loss.Reconstruction-given the significant post-traumatic deformity and bone loss, a hinged knee replacement was indicated.Enough residual distal femur was present, thus the decision to use a distal femoral replacement was deferred.Extensive scar tissue and osteolytic bone was removed.The patella was then debrided of scar tissue and the button was removed with a saw.Devices were trialed and then implanted.

• Brand Name: CC TIBIAL INSERT SZ 2, 18MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17217109
• Report Number: 1038671-2023-01489
• Device Sequence Number: 6232334
• Product Code: JWH
• UDI-Device Identifier: 10885862054203
• UDI-Public: 10885862054203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 07/02/2026

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: 06/17/2012
• Device Model Number: 208-22-18
• Device Catalogue Number: 208-22-18
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 07/25/2026
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 06/28/2023; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2007
• 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: A
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female