MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT STD, SZ 2, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-010-03-0220 - logic cr femoral cem, left sz 2 sn: (b)(4), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t sn: (b)(4), 200-02-32 - three peg patella 32mm sn: (b)(4).
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2017.The patient had a poly exchange and was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
H3: 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 poly swap/revision was reported to be due to device recall.No other reason reported.H7: z-0021-2022.
Additional Manufacturer Narrative
As a result of additional information received, b5 and h6 have been updated.H3: re-opened investigation results - the reason for the revision cannot be confirmed from the information provided, but does not appear to be due to loosening as reported since only the tibial insert was revised.The reason for the revision may be due to inclusion of the implanted polyethylene tibial insert in the packaging recall.However, this could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.Initial submission: fields in section f10 should be blank, this is a manufacturer's report.
Event or Problem Description
As reported by the legal department, approximately 5.5 years post op the initial tka, this female patient was revised.The patient developed loosening of the device and pain in her knee.No other patient information/medical history provided.Unable to obtain photos or x-rays.Device was not available for return; the hospital will not allow release.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The reason for the revision cannot be confirmed from the information provided, but does not appear to be due to loosening as reported since only the tibial insert was revised.The reason for the revision may be due to inclusion of the implanted polyethylene tibial insert in the packaging recall.However, this could not be confirmed as no images or radiographs were provided and the devices were not available 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 STD, SZ 2, 11MM
• 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: 15369694
• Report Number: 1038671-2022-01039
• Device Sequence Number: 6277332
• Product Code: JWH
• UDI-Device Identifier: 10885862174253
• UDI-Public: 10885862174253
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2026

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: 07/29/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2, 11MM
• Device Catalogue Number: 02-012-47-2011
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 09/25/2023; 01/28/2026
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/31/2022; 10/04/2023; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female