MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 2F/1T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 2, 11MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tka in (b)(6) 2008.The patient was brought back for right knee pain, which appeared to be tibial loosening.The insert was removed.The femur was checked and found to be well fixed.Attention turned to the tibia and it was found to be loose.The tibia was removed.A new tibia, stem and insert were implanted.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 200-02-29 - three peg patella 29mm sn: (b)(4), 200-04-21 - cemented finned tib.Tra sz 2f/1t sn: (b)(4), 230-03-02 - optetrak asy,cr cemented femoral, sz 2, sn: (b)(4), 620-00-02 - platelet rich plasma kit with spray tips sn: (b)(4), 620-11-02 - accelerate conc.Sys rep by 620-12-02 sn: (b)(4).
Additional Manufacturer Narrative
H3: the revision reported was likely the result of aseptic loosening of the tibial tray after 14 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation and limited clinical information was available to assess possible contributions from patient-related conditions and/or initial implant alignment to the reported event.H7: z-0019-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 had an initial (b)(6).The patient was brought back for right knee pain, which appeared to be tibial loosening.The insert was removed.The femur was checked and found to be well fixed.Attention turned to the tibia and it was found to be loose.The tibia was removed.A new tibia, stem and insert were implanted.The patient was last known to be in stable condition following the event.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 2F/1T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15361589
• Report Number: 1038671-2022-01037
• Device Sequence Number: 12267851
• Product Code: JWH
• UDI-Device Identifier: 10885862039699
• UDI-Public: 10885862039699
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• 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): 02/26/2026

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: 01/08/2012
• Device Model Number: CR TIBIAL INSERT SZ 2, 11MM
• Device Catalogue Number: 200-04-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 02/23/2026
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 12/13/2022; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2007
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female