MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic tibia fit tray 4f/4t, logic cr femoral cem, right, sz 4 (cat# 02-010-03-0340), and 3 peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six years post initial right side tka, the 59 y/o female patient presented back to surgeon office with complaints of dissatisfaction, pain, and swelling of the right primary knee.An examination and imaging were performed showing poly wear and osteolysis.The poly turned out to be an implant highly likely involved in the recall.The patient was scheduled for a complete revision of the right total knee on (b)(6) 2020.All of the exactech implants were removed and a total revision using competitor's knee was re-implanted.The patient is last known to be stable.Photos and x-rays received.The device is not available for evaluation due to devices discarded.Revision happened in the past.
Additional Manufacturer Narrative
(h3) the revision reported is most likely the result of prosthesis wear secondary to contributions from instability, axial rotation mismatch between the tibial and femoral components, and patient-related issues including obesity.
Additional Manufacturer Narrative
Concomitant products: 2699120, 02-010-03-0340 - logic cr femoral cem, right, sz 4 2789054, 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t 3548380, 200-02-32 - three peg patella 32mm these devices are used for treatment not diagnosis.There is no additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 component code, types of investigation, investigation findings and investigation conclusion.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 9MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16495675
• Report Number: 1038671-2023-00382
• Device Sequence Number: 6451790
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 06/27/2020
• Device Model Number: CR TIBIAL INSERT 9MM
• Device Catalogue Number: 02-012-47-4009
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: Not provided; 06/10/2024; 04/23/2026
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/26/2024; 06/10/2024; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2012
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 130 KG