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

Catalog Number	208-22-09
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right knee revision on (b)(6) 2009 and then approximately 12 years, 9 months later experienced a second knee revision on (b)(6) 2022.Patient experienced prosthesis wear, femoral loosening, synovitis, osteolysis and pain.Revision operative report 30 aug 2022-preliminary diagnosis: 1.Recalled right knee implant, 2.Aseptic loosening right total knee replacement.Revision right total knee replacement, all components.Revision to competitor¿s devices.Indication- patient had intermittent pain.Mri showed significant concerning areas for loosing and synovitis as well as areas of osteolysis.-the femur was noted to be grossly loose with gently interruption of the bone cement interface.There was tremendous grade to a bone loss of the proximal femur with almost complete loss of the lateral femoral condyle.Debris was cleaned and a complete synovectomy was performed.-the tibia was noted to be well fixed.It was removed.-the patella was easily removed, there was subimplant osteolysis.New devices were trialed and then implanted.A sterile compressive dressing was placed the patient awakened transferred to the recovery room there were no complications of the procedure.The patient was transferred to stable condition to recovery unit.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.
Additional Manufacturer Narrative
Report number: 1038671-2023-01968 the product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01968 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, the patient underwent a right total knee replacement surgery.Approximately 12 years and 9 months later, the patient was revised for a second time.Because the patient has filed a legal claim, it appears that they are alleging prosthesis wear of an exactech polyethylene device.Per the available information, it also appears that the patient is alleging femoral loosening.Per the revision operative notes, "postoperatively [following the first revision] they continued to have intermittent pain that is worsened recently.In the interim the knee has been recalled.Mri was obtained and showed significant concerns for loosening and synovitis as well as areas of osteolysis.The femur was noted to be grossly loose with gentle interruption of the bone cement interface with a flexible osteotome the femur was removed with no bone loss due to removal.There was tremendous bone loss of the proximal femur with almost complete loss of the lateral femoral condyle.Debris was cleaned and a complete synovectomy was performed.The tibia was noted to be well fixed.".
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.In august of 2021, it was discovered that a bag used in the packaging of our polyethylene inserts had been produced outside of our quality specifications.The use of these non-conforming bags may enable increased oxygen diffusion to the uhmwpe (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with bags that conform to specifications.For inserts with greater than five years of shelf life, increased oxidation of the inserts can lead to premature polyethylene wear resulting in a revision surgery.However, while it was packaged in a non-conforming vacuum bag, this tibial insert was on the shelf for less than 5 years before it was implanted.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user- and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: CC TIBIAL INSERT 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21246361
• Report Number: 1038671-2025-00446
• Device Sequence Number: 3627522
• Product Code: JWH
• UDI-Device Identifier: 10885862054166
• UDI-Public: 10885862054166
• 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: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 09/14/2014
• Device Catalogue Number: 208-22-09
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2009
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female