MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-22-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Scar Tissue (2060)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2024-00733 report number " d10: 200-01-02 - cemented cr femoral sz 2.200-02-29 - three peg patella 29mm.204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00733.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and bone fracture.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.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.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
It was reported via legal documentation that a patient had a total left knee arthroplasty and then experienced a surgical revision approximately 8 years, 7 months after implant.Revision operative report of postoperative diagnosis: failed left knee.Preop indication: failed left primary knee, with gross loosening of the tibial component to periprosthetic fracture.Patient was revised to stryker devices.Findings: negative for acute inflammation but periprosthetic fracture to the tibia with anterior perforation and significant posterior bone loss on the tibia.Significant polyethylene wear and gross failure of the tibial component with posterior and varus clap with perforation and periprosthetic fractures through the medial tibial plateau.Femoral component was slightly internally rotated.The patient tolerated the procedure well, there were no immediate complications.(op report attached).There is no other patient demographic or medical history available.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: CR TIBIAL INSERT SZ 2, 13MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21398474
• Report Number: 1038671-2025-00941
• Device Sequence Number: 9208807
• Product Code: JWH
• UDI-Device Identifier: 10885862040213
• UDI-Public: 10885862040213
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2012
• Device Catalogue Number: 200-22-13
• 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: 02/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 08/13/2007
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female