MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 13MM; SEE H10

Catalog Number	208-25-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, underwent initial right knee replacement surgery on (b)(6) 2012 and was implanted with an optetrak polyethylene tibial insert.On (b)(6) 2022, plaintiff underwent right knee revision surgery, approximately 10 years 5 months post initial procedure, due to ¿osteolysis,¿ ¿aseptic loosening of [the] femoral component¿ and ¿wear of the [polyethylene] liner with delamination.¿ plaintiff's right knee revision surgery was due to accelerated and preventable wear of the optetrak polyethylene tibial insert.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Added information to section e4.H6: investigation results - the revision reported in (b)(4) may have been the result of polyethylene wear, osteolysis, and femoral loosening as stated in the legal documentation.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and an insufficient bond between the femoral component and the bone.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the explanted devices were not returned for evaluation and radiographs, photographs, or operative notes were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6 the following sections were corrected: h6 mdr section codes updated/corrected: a, b, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and patellar 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 manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and full product information 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, 13MM
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16502352
• Report Number: 1038671-2023-00389
• Device Sequence Number: 17707049
• Product Code: JWH
• UDI-Device Identifier: 10885862054425
• UDI-Public: 10885862054425
• 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: 2012
• Device Explanted Year: 2022
• 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): 01/27/2025

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: 12/09/2014
• Device Catalogue Number: 208-25-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/01/2023; 01/24/2025
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 08/10/2023; 08/10/2023; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2009
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown