MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an 80 yo female patient, initial right knee implanted on (b)(6) 2019, underwent a revision on (b)(6) 2022, approximately 3 years 8 months post the initial procedure.The full knee was revised.Loosening of femur due to significant poly wear (patella and tibia) were indicated.The patient was last known to be in stable condition following the event.No devices returning as they were disposed of by the hospital.
Additional Manufacturer Narrative
Concomitant medical products: 2822789, 02-010-03-0335, logic cr femoral cem, right, sz 3.5, 323871, 203-96-40, (11-3661) stryker sys 6 90x25x1.27, 332364, 203-96-42, (11-3671) stryker sys 6 90x13/21x1.19, 5279765, 201-78-15, holding pin mini sharp point 4 pk, 5284137, 201-78-81, 3 trocar, mod.Hex 2pk, 5284161, 201-78-81, 3 trocar, mod.Hex 2pk, 5284175, 201-78-81, 3 trocar, mod.Hex 2pk, 5404146, 02-012-45-3535, lgc tibial fit tray cem sz 3.5f / 3.5t, 6038382, 200-02-41, three peg patella 41mm, s010942, 521-78-36, threaded pin size 5.1 collarless, s018337, 521-78-23 , threaded pin size 2.3 collared, s018357, 521-78-23, threaded pin size 2.3 collared.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
D10: concomitants: 02-010-04-0340 - logic cr femoral por, right, sz 4, (b)(6).02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t, (b)(6).200-02-41 - three peg patella 41mm (b)(6), b5, d4, d6a, d10, h4.
Event or Problem Description
Initial right knee implanted on (b)(6), 2018, underwent a revision on (b)(6), 2022, approximately 4 years 8 months post the initial procedure.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported was likely the result of femoral loosening and prosthesis wear of the tibial insert and patella component.The wear may have been due to a combination of third body wear, positioning of the components, and/or patient related conditions.The reported loosening may have been due to an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.It is unclear if the reported loosening may have contributed to the wear or if the wear may have contributed to the reported loosening.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b4, d1, d4, h6 -health effect - clinical code, medical device problem code, component code, type of investigation, investigation conclusion and h11.The revision reported was likely the result of femoral loosening and prosthesis wear of the tibial insert and patella component.The wear may have been due to a combination of third body wear, positioning of the components, and/or patient related conditions.The reported loosening may have been due to an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.However, this cannot be confirmed because the components were not returned for evaluation and radiographs were not provided.It is unclear if the reported loosening may have contributed to the wear or if the wear may have contributed to the reported loosening if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
This is report 1 of 3 for this event/patient.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 4, 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: ashley harris ; 3523771140
• MDR Report Key: 15777355
• Report Number: 1038671-2022-01446
• Device Sequence Number: 20107863
• Product Code: JWH
• UDI-Device Identifier: 10885862174482
• UDI-Public: 10885862174482
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 09/28/2023
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM
• Device Catalogue Number: 02-012-48-4009
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 02/20/2023; 03/31/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 11/29/2022; 03/14/2023; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female