MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, 6 years and 2 months post the initial bilateral tka, a bone scan showed low level heat on both knees.The surgeon removed the poly tibial inserts and left side patella, which all showed evidence of wear and mild osteolysis.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.
Additional Manufacturer Narrative
Pending investigation.D10: 4256423 02-010-04-0230 - logic cr femoral por, left, sz 3 4741814 02-010-04-0330 - logic cr femoral por, right, sz 3 4359419 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 5353907 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 5307276 200-02-35 - three peg patella 35mm 5248730 201-78-15 - holding pin mini sharp point 4 pk 5342792 201-78-81 - 3 trocar, mod.Hex 2pk 5342797 201-78-81 - 3 trocar, mod.Hex 2pk 5342799 201-78-81 - 3 trocar, mod.Hex 2pk 5144579 521-78-23 - threaded pin size 2.3 collared 5235161 521-78-23 - threaded pin size 2.3 collared 5340746 521-78-23 - threaded pin size 2.3 collared 4052750 521-78-36 - threaded pin size 5.1 collarless 01000018034 (b)(6) - gps implant kit v2 12001017003 (b)(6) - gps implant kit v2 unassigned 200-00-00 - knee item-misc.
Additional Manufacturer Narrative
H3: the reason for the revision reported may have been due to prosthesis wear; however, the wear could not be confirmed based on the images provided for the patella component and the 9mm insert.The observed wear on the 11mm insert may have been due to implant positioning and/or third body wear.However, this cannot be confirmed because the components were not returned for evaluation and no radiographs or relevant clinical information was provided.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19964638
• Report Number: 1038671-2024-02790
• Device Sequence Number: 8867398
• Product Code: JWH
• UDI-Device Identifier: 10885862174352
• UDI-Public: 10885862174352
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 02/07/2023
• Device Catalogue Number: 02-012-47-3011
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male