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

Catalog Number	02-012-48-3009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/23/2021
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 team, approximately three years post initial tka, the (b)(6)female patient was diagnosed with failed right total knee arthorplasty and underwent revision surgery.During the revision surgery, patient's surgeon stated, "patient had a previous right total knee arthroplasty.This had failed secondary to catastrophic polyethylene wear.This created large cysts within both the medial and lateral posterior condyles, as well as the medial aspect of the proximal tibia.Surgeon removed the polyethylene, which was noted lo have severe polyethylene wear." following the revision surgery, patient continues to be limited in patient's activities of daily living.Patient has difficulty with daily activities such as getting dressed, climbing stairs, and bathing.As a direct result, patient has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort, gait impairment, poor balance, difficulty walking, component part loosening, soft tissue damage, bone loss, and other injuries presently undiagnosed, which all require ongoing medical care.
Additional Manufacturer Narrative
Product information has been identified.The following fields have been updated, accordingly: d10.Concomitants: 02-010-03-0330 - logic cr femoral cem, right, sz 3 (b)(6).02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t (b)(6).H6: investigation results - the revision reported was likely the result of wear of the tibial insert, which may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation and no images or radiographs were provided.Additionally, a contributing factor to the wear may have been the result of the insert being packaged in a non-conforming vacuum bag for more than five years.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Additional information fields: a2, b2, g, g2 corrected fields: e1, h6-clinical code and component code.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14421190
• Report Number: 1038671-2022-00557
• Device Sequence Number: 12144419
• Product Code: JWH
• UDI-Device Identifier: 10885862174383
• UDI-Public: 10885862174383
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 02/27/2020
• Device Catalogue Number: 02-012-48-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/26/2023; 08/14/2023; 04/02/2025
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/11/2023; 03/06/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2012
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female