MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	OPTETRAK CR TIBIAL INSERT
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, in (b)(6) 2012, patient (55-year-old at the time) underwent this tka surgery in his right knees where the surgeon implanted defendants¿ optetrak, cr, porous femoral component, optetrak, finned, cemented tibial tray, optetrak, cr tibial insert, and patella single peg.The allegations in this complaint relate to the early failure of the defective device, its tibial tray and its polyethylene component.The subsequent revision surgeon noted that there was catastrophic failure with fracture of the polyethylene insert as well as a tibial insert component with metal-on-metal articulation bilaterally.The components of the device were defective, unreasonably dangerous and failed resulting in loosening, malpositioning of the implant, and rubbing/wear of the components causing metallosis, instability, limited mobility, swelling and pain.The extent of the components¿ failure was discovered upon patient¿s right knee revision surgery on (b)(6) 2021.
Additional Manufacturer Narrative
H6: investigation results - the revisions reported may have been due to prosthesis wear/fracture of the tibial inserts, which allowed for loosening, malalignment of the implants, and metal-on-metal contact between the femoral component and tibial tray and resulted in the reported metallosis, instability, limited mobility, swelling, and pain.However, these allegations cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices, pre-revision radiographs, part information, and operative notes were unable to be obtained.
Additional Manufacturer Narrative
H6: added clinical codes, medical device code and component code d10: (b)(6) 200-73-09 - cr tibial insert sz 3, 9mm, slope ++ (b)(6) 232-03-03 - optetrak asy, cr porous femoral, sz 3, right (b)(6) 200-03-35 - one peg patella 35mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h6.Mdr section codes updated/corrected: a, b, c, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, fracture, 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: CR TIBIAL INSERT SZ 3, 9MM, SLOPE ++
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15943316
• Report Number: 1038671-2022-01586
• Device Sequence Number: 17694689
• Product Code: JWH
• UDI-Device Identifier: 10885862041258
• UDI-Public: 10885862041258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/30/2025

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: 09/14/2015
• Device Model Number: OPTETRAK CR TIBIAL INSERT
• Device Catalogue Number: 200-73-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 06/30/2023; Not provided; 05/29/2025
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 08/11/2023; 12/02/2024; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2010
• 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: 61 YR
• Patient Sex: Male