MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 9MM, SLOPE ++; CEMENTED FINNED TIB. TRA SZ 4F/4T

Model Number	200-04-44
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 9.5 yrs postop tka, a fairly active (b)(6) y/o male patient complained of pain, instability, and loosening.Also ¿slow swelling¿ and decreased range of motion started 4-5 years ago¿.Fluid was drained to test for infection and was negative.Patient was revised to a hinged knee.Pt reported surgeon noted cement coming apart, loose plastic, and osteolysis at site, al devices were removed and replaced.Pt complained that this recovery was much more painful that the initial implant recovery.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the reported event was likely the result of a prosthesis wear and aseptic loosening of the femoral component.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contributions of loosening, prosthesis wear, and component alignment to the sequence of events cannot be determined as the devices were not available for evaluation and radiographs from the index surgery were not available.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2010.They underwent right knee revision surgery on (b)(6) 2020, approximately 9 years 8 months post primary procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a complaint in a coordinated action in alachua county with master case no.(b)(4).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
As a result of additional information received, the following fields have been updated: a2, b5, d1, d4, d6a, d8, d10, g2, g4, h4, h6, h7, and h9.Further information and/or re-opened investigation results will be provided within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results: the revision reported was likely the result of a prosthesis wear and aseptic loosening of the femoral component secondary to issues with component sizing and alignment.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contributions of loosening, prosthesis wear, and component alignment to the sequence of events cannot be determined as the devices were not available for evaluation and radiographs from the index surgery were not available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of pain, loss of range of motion, aseptic loosening, and instability.The loosening may have been caused by improper component sizing and alignment, which led to an increase in cement and bone particles in the joint space and prosthesis wear.However, the contributions of loosening, prosthesis wear, component alignment and the sequence of events cannot be determined as the devices were not available for evaluation and radiographs from the index surgery were not available.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ 4, 9MM, SLOPE ++
• Common Device Name: CEMENTED FINNED TIB. TRA SZ 4F/4T
• 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 ; 3523782617
• MDR Report Key: 10051680
• Report Number: 1038671-2020-00290
• Device Sequence Number: 13674636
• Product Code: JWH
• UDI-Device Identifier: 10885862041296
• UDI-Public: 10885862041296
• Combination Product (Y/N): N
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/04/2025

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: 12/01/2013
• Device Model Number: 200-04-44
• Device Catalogue Number: 200-74-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 09/29/2023; 10/11/2023; 03/03/2025
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 03/11/2021; 09/29/2023; 11/20/2023; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male