MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 1, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	208-21-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, a patient had their first left knee revision surgery on (b)(6) 2009.They subsequently underwent another left knee revision on (b)(6) 2016, approximately 7 years after their first revision.(b)(6) 2016 op report postoperative diagnosis: left knee failed total knee replacement with gross instability.The surgeon noted that the polyethylene had some early wear and was removed.The femoral component was removed without the stem, and the stem was disimpacted from the femur.The tibial component could not be disengaged from the stem.A tibial tubercle osteotomy was required, which was planed preoperatively.The fragment flipped laterally.The surgeon also noted there was a large amount of bone medially where it appeared there may been a medial epicondylar fracture that it healed.There was also significant bone loss and significant amount of cement, which created a large void.The patella was noted to have minimal wear, however, there was marked osteophytes surrounding the patella.The patella was noted as well fixed.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
1038671-2025-00282, 1038671-2025-00283 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1, d4, g4, h4, h6 (component code, type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, medical device problem code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and bone fracture or due to inclusion of the polyethylene in the packaging recall.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 1, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17405378
• Report Number: 1038671-2023-01795
• Device Sequence Number: 12542986
• Product Code: JWH
• UDI-Device Identifier: 10885862054104
• UDI-Public: 10885862054104
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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
• Device Expiration Date: 06/15/2013
• Device Catalogue Number: 208-21-13
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female