MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-22-15
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Bone Fracture(s) (1870); Failure of Implant (1924); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561); Joint effusion (4849)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: 04180 203-96-02 - (11-2324) saw blade new stryk (.035) 09209 203-96-01 - (11-2222) saw blade new stryk (.050) 0y209 203-96-03 - (11-2216) saw blade new stryker (.050) 2136347 204-34-04 - fluted stem extension 40l x 14 mm 2143673 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t 2158556 200-02-29 - three peg patella 29mm 8266814 210-01-02 - nmc femoral sz 2.The device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 129 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of left knee total knee arthroplasty prosthesis with loose components; cortical fracture of left femur; severe osteolysis, loss of range of motion; chronic pain; injuries to tissue and cone of the left knee; subchondral cyst; joint effusion; metallosis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Corrected fields: b2, h6: type of investigation.Updated fields: a2-3.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral bone fracture, disassembly, loss of range of motion, patellar loosening, 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.H6: corrected health effect, medical device, and investigation clinical codes.

• Brand Name: CC TIBIAL INSERT SZ 2, 15MM
• 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 ; 3523771140
• MDR Report Key: 19314799
• Report Number: 1038671-2024-01244
• Device Sequence Number: 7003924
• Product Code: JWH
• UDI-Device Identifier: 10885862054197
• UDI-Public: 10885862054197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: 03/06/2013
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: Not provided; 01/23/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 12/05/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female