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

Model Number	02-012-49-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient was revised on (b)(6) 2023 as the poly had delaminated.There was no reported breakage of devices or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: (b)(4), 02-010-03-0330 - logic cr femoral cem, right, sz 3.(b)(4), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(4), 200-02-35 - three peg patella 35mm.Recall number: z-0021-2022.
Additional Manufacturer Narrative
H3: the revision reported was most likely the result of prosthesis wear initiated by unintended contact between the tibial insert and trochlear ridges of the femoral component.Potential contributing factors to the sequence of events may include instability of the knee joint, component alignment, and/or patient-related conditions.However, this cannot be confirmed as the devices were not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6, h11.No device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified that the provided image of the explanted tibial insert appears to have retained biologic fluid.The insert appears unremarkable except for two well-defined parallel grooves on the articular surfaces of the insert.The location and pattern of wear appears to be consistent with contact from the ridge defining the trochlear groove of the femoral component during knee extension.This may suggest hyperextension due to anatomic instability and/or due to relative alignment of the tibial and femoral components.This may occur if the femoral component is implanted in flexion or secondary to a combination of a tibial tray implanted in greater than 5 degrees of posterior inclination and use of the cr++ insert which has 6 degrees of posterior slope built into the polyethylene.Instability occurs when the soft-tissue structures around the knee are unable to provide the stability necessary for adequate function during standing or walking.Instability may be the result of increased soft-tissue laxity (looseness), insufficient tensioning, or improper positioning/malalignment of the prosthesis.Uneven pressure distribution from instability and malalignment can subsequently result in early wear of the polyethylene component.The parallel grooves on the image of the explanted tibial insert may indicate that wear on the articular surface of the tibial insert was initiated by contact against the ridge of the trochlear groove on the femoral component, possibly secondary to component malalignment and/or knee instability.However, this cannot be confirmed as the devices were not returned for evaluation.The provided radiograph appears unremarkable for indicators of wear and/or rotational malalignment.An accurate assessment of posterior inclination of the tibial tray cannot be made without a full leg radiograph.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from prosthesis wear initiated by unintended contact between the tibial insert and trochlear ridges of the femoral component.Potential contributing factors to the sequence of events may include instability of the knee joint, component alignment, and/or patient-related conditions.However, this cannot be confirmed as the devices 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.

• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16419980
• Report Number: 1038671-2023-00205
• Device Sequence Number: 15061127
• Product Code: JWH
• UDI-Device Identifier: 10885862174413
• UDI-Public: 10885862174413
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 02-012-49-3009
• Device Catalogue Number: 02-012-49-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 04/21/2026
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/12/2023; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female