MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal brief, patient's initial total knee arthroplasty was performed on (b)(6) 2018.Patient's underwent revision total knee arthroplasty on (b)(6) 2021 due to premature failure of his exactech optetrak total knee device.
Additional Manufacturer Narrative
Concomitant medical products.Logic cr femoral cem, left sz 1.5 (cat# 02-010-03-0215 / serial# 4412158) three peg patella 29mm (cat# 200-02-29 / serial# 5307110) lgc tibial fit tray cem sz 1.5f / 1.5t (cat# 02-012-45-1515 / serial# 4231840) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
As reported by legal brief, patient's initial total knee arthroplasty was performed on (b)(6) 2018.Patient's underwent revision total knee arthroplasty on (b)(6) 2021 due to premature failure of his exactech optetrak total knee device.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; no reason for revision was given.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Section b5: additional information received from legal brief indicates that during revision surgery, patient¿s surgeon stated, ¿we were able to lever the polyethylene plastic with a small osteotome and after this was retrieved, we then inspected the plastic, noted to have pitting and delamination of the medial aspect of the tibial polyethylene.Otherwise, the polyethylene looked to be in good condition laterally¿.Despite undergoing revision surgery, patient experience daily pain and discomfort in patient¿s left knee which limits patient¿s activities of daily living and impacts patient¿s quality of life.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of wear of the tibial insert.However, the cause of the wear could not be determined because the component was not returned for evaluation and images were not provided.Additionally, the insert was packaged in a non-conforming vacuum bag for more than five years, which may have contributed to the reported wear.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event,.Associated report: 1038671-2024-04477.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, loosening and/or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM
• 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: 14824552
• Report Number: 1038671-2022-00722
• Device Sequence Number: 4677639
• Product Code: JWH
• UDI-Device Identifier: 10885862144423
• UDI-Public: 10885862144423
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/22/2024

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: 08/11/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 1.5, 13 MM
• Device Catalogue Number: 02-012-49-1513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 02/01/2023; 02/27/2023; 11/21/2024
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 09/24/2022; 02/21/2023; 03/02/2023; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female