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

Model Number	LOGIC CR TIB INSERT STD, SZ 4, 9MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-010-03-0240 - logic cr femoral cem, left, sz 4 (b)(4), 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t (b)(4), 200-02-32 - three peg patella 32mm (b)(4), 201-78-12 - holding pin lg head sharp point med 2pk (b)(4), 201-78-15 - holding pin mini sharp point 4 pk (b)(4), 201-78-81 - 3" trocar, mod.Hex 2pk (b)(4), (b)(4).Recall: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2018.The patient was revised on (b)(6) 2022 due to the recall.No other patient information/medical history reported.
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 has been reported to be due to the device recall; no other reason reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2022-00721.

• Brand Name: LOGIC CR TIB INSERT STD, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15526195
• Report Number: 1038671-2022-01214
• Device Sequence Number: 17661988
• Product Code: JWH
• UDI-Device Identifier: 10885862174444
• UDI-Public: 10885862174444
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 4, 9MM
• Device Catalogue Number: 02-012-47-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 03/13/2025
• Initial Report FDA Received Date: 10/02/2022
• Supplement Report FDA Received Date: 11/04/2022; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 76 YR
• Patient Sex: Male