MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 9MM; SEE H10

Model Number	02-012-65-5015
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Joint effusion (4849)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical product(s): 02-010-06-0350 - logic cc femoral size 5, right, 4948442; 02-010-06-0551 - logic post.Aug.Block size 5, 5mm, 4858435, 4858469; 02-010-06-0552 - logic post.Aug.Block size 5, 10mm, 4450844.Pending investigation.
Event or Problem Description
It was reported via legal notification that on (b)(6) 2008, a patient underwent right total knee replacement surgery where he was implanted with an optetrak cc polyethylene tibial insert (serial #: (b)(4)); then on (b)(6) 2017, approximately 9 years after implant, underwent a right knee revision surgery due to accelerated and preventable wear of the optetrak cc polyethylene tibial insert.During this revision procedure, the patient was implanted with a second optetrak logic cc polyethylene tibial insert (serial #: (b)(4)).It is stated that the patient experiences pain in his right knee and will likely require a re-revision surgery of the right knee to remove the polyethylene liner.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6: investigation results - the revision reported in (b)(4) was likely the result of polyethylene wear as stated in the legal documentation.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation and radiographs, photographs, or operative notes were not provided.As a result of the investigation, the correct product information was identified.The following fields have been corrected: d1, d4, g4, h4, and h9.
Additional Manufacturer Narrative
The revision reported may have been the result of prosthesis wear.Contributing factors to the wear may have been orientation of the components and/or the tibial insert being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed because the components were not returned for evaluation 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening 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 5, 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16702480
• Report Number: 1038671-2023-00618
• Device Sequence Number: 20251633
• Product Code: JWH
• UDI-Device Identifier: 10885862054401
• UDI-Public: 10885862054401
• 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: 2008
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2011
• Device Model Number: 02-012-65-5015
• Device Catalogue Number: 208-25-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 02/24/2025; 03/11/2025
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 08/08/2023; 02/25/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male