MAUDE Adverse Event Report: EXACTECH, INC. 234-02-03; OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,

Model Number	234-02-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical devices: three peg patella 35mm (cn: 200-02-35, sn: (b)(4)) trapezoid tibial tray sz 3f/4t (cn: 204-04-34, sn: (b)(4)) ps tibial inserts sz 3, 13mm (cn: 204-23-13, sn: (b)(4)).Initial reporter's occupation: attorney.
Event or Problem Description
Initial implant: (b)(6) 2014.Left knee revision date: (b)(6) 2019, hospital: unknown, surgeon: unknown as reported, approximately 5 years postop the initial implant, a patient experienced a left knee device failure and was defective because of aseptic loosening of the femoral and tibial components, substantial and defective polyethylene wear, including particulate debris of the plastic polyethylene insert found throughout the knee area, polyethylene wear resulting in loosening of the device around the worn polyethylene insert area.No other information has been received.
Event or Problem Description
As reported, approximately 5 years postop the initial implant, a patient experienced a left knee device failure and was defective because of aseptic loosening of the femoral and tibial components, substantial and defective polyethylene wear, including particulate debris of the plastic polyethylene insert found throughout the knee area, polyethylene wear resulting in loosening of the device around the worn polyethylene insert area.No other information has been received.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision reported was likely the result of tibial insert wear and an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the femoral and tibial components.However, this cannot be confirmed as the devices were not returned and x-rays were not provided.(d11) concomitant device: - three peg patella 35mm (cn: 200-02-35, sn: (b)(6)) ;- trapezoid tibial tray sz 3f/4t (cn: 204-04-34, sn: (b)(6)) ;- ps tibial inserts sz 3, 13mm (cn: 204-23-13, sn: (b)(6)).(e3) initial reporter's occupation: attorney.Section(s): no information has been provided: a2, a4, a5, and b6.The following section(s) have additional info; g4, g7, h1, h2, h3, and h7.
Additional Manufacturer Narrative
(h3) update: the case was reopened because the components were temporarily provided to exactech for evaluation.The updated evaluation noted in the revision reported is multi-factorial.The wear/fracture of the ps post of the tibial insert was likely the result of a combination of an alignment discrepancy, joint instability, and/or rotational mismatch between the tibial components and the femoral component, which created significant stress on the ps post, uneven wear of the articular surfaces, and uneven force distribution across the joint.These conditions could also contribute to loosening of the prostheses.It is unclear if the tibial insert was fully seated at the time of implantation, possibly due to protrusion of the medial posterior screw hole cover, which appears to have led to cracking of the insert and detachment of the locking button.(d11) concomitant device: three peg patella 35mm (cn: 200-02-35, sn: (b)(6)).Trapezoid tibial tray sz 3f/4t (cn: 204-04-34, sn: (b)(6)).Ps tibial inserts sz 3, 13mm (cn: 204-23-13, sn: (b)(6)).(e3) initial reporter's occupation: attorney.
Additional Manufacturer Narrative
B5: the optetrak devices implanted in the patient contained several components, including a posterior stabilized tibial insert made of defendants¿ proprietary ultra- high molecular weight polyethylene (¿uhmwpe¿ or ¿polyethylene¿).After implantation of the optetrak on (b)(6) 2014, plaintiff experienced pain and other symptoms and was ultimately diagnosed in 2019 with a failed left tka.

• Brand Name: 234-02-03
• Common Device Name: OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 3,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 10013699
• Report Number: 1038671-2020-00282
• Device Sequence Number: 3318957
• Product Code: JWH
• UDI-Device Identifier: 10885862063199
• UDI-Public: 10885862063199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2023

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: 03/07/2017
• Device Model Number: 234-02-03
• Device Catalogue Number: 234-02-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 08/16/2020; 06/03/2021; 02/08/2023
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 08/18/2020; 06/21/2021; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2012
• 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