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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, this 75 year old female patient had a right tka 6 years ago.She had great pain relief for 4 years then noticed increasing pain and swelling over the last 2 years.She received a letter regarding the recall and presented to her surgeon with pain and instability.The patient was revised at an unknown date with a polyethylene exchange and a synovectomy.No sever osteolysis.Complete revision condylar constrained: femoral osteolysis, tibial osteolysis.Complete revision requiring hinge.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of contributions from patient-related conditions, instability, and/or rotational malignment between the femoral and tibial components, which lead to the reported prosthesis wear and pain.Inclusion of the implanted polyethylene in the packaging recall may also have been a contributing factor.However, the contributions of each to the sequence of events cannot be confirmed because the components were not returned for evaluation and manufacturing information was not provided.
Additional Manufacturer Narrative
Correction/additional information: b4, d1, d2a, d2b, d4, d10, h4, h6.
Event or Problem Description
The female patient's femur had an increased posterior dwell point- whether the sloped poly or a compromised pcl was the root cause is unclear.This likely led to the early delamination of the posterolateral aspect of the poly bearing.There was also significant osteolysis under the posterior condyles- although the femur wasn¿t grossly loose.Patient was revised to a competitor's devices.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: concomitant products: - logic cr femoral cem, right, sz 3 (cat# 02-010-03-0330 / serial# (b)(6)).- lgc tibial fit tray cem sz 3f / 3t (cat# 02-012-45-3030 / serial# (b)(6)).- three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)).- collar fixation pin 2pk 40mm, quick release (cat# 201-78-82 / serial# (b)(6)).- kms1312.M62 90x13x1.19mm (cat# 203-96-50 / serial# (b)(6)).- threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(6)).The revision reported was likely the result of contributions from patient-related conditions, instability, and/or rotational malignment between the femoral and tibial components, which lead to the reported prosthesis wear and pain.Inclusion of the implanted polyethylene in the packaging recall may also have been a contributing factor; however, the contributions of each to the sequence of events cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e1 country, and g3 correct date received by manufacturer on initial report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a/d6b.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15888096
• Report Number: 1038671-2022-01539
• Device Sequence Number: 5078437
• Product Code: JWH
• UDI-Device Identifier: 10885862174383
• UDI-Public: 10885862174383
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 11/05/2020
• Device Catalogue Number: 02-012-48-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 03/13/2023; 03/13/2023; 12/11/2024; 11/02/2022; 06/25/2025
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/31/2023; 08/23/2023; 12/18/2024; 04/11/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female