MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC CR TIB INSERT STD, SZ 5, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 56 year old male patient had an initial left tka on (b)(6) 2018.The patient was revised on (b)(6) 2024 due to a failed logic poly insert.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation as they were disposed at hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
Section d10: concomitant products 4009297 - 02-010-04-0350 - logic cr femoral por, right, sz 5 4904073 - 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t unassigned - 200-00-00 - knee item-misc 5307224 - 200-02-38 - three peg patella 38mm 5132334 - 201-78-15 - holding pin mini sharp point 4 pk 5340585 - 521-78-23 - threaded pin size 2.3 collared 5340591 - 521-78-23 - threaded pin size 2.3 collared 5082672 - 521-78-36 - threaded pin size 5.1 collarless 12001017079 - a10012 - gps implant kit v2 additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported may have been the result of malalignment between the femoral and tibial components, third body wear, instability, or any combination of these, which led to prosthesis wear.However, this could not be confirmed as the device was not returned for evaluation.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: geoff gannon
• MDR Report Key: 19260072
• Report Number: 1038671-2024-01088
• Device Sequence Number: 6493231
• Product Code: JWH
• UDI-Device Identifier: 10885862174550
• UDI-Public: 10885862174550
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 06/11/2022
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 5, 11MM
• Device Catalogue Number: 02-012-47-5011
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male