MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this 74 y/o female patient called to confirm if her liner was part of the recall.She states she has had pain and swelling in her knee for several years and was told by her surgeon her knee is fine and there is nothing else he can do for her.She was also upset her surgeon did not notify her about the recall and was told by his office her knee was not part of the recall."she no longer can drive due to the revised knee".Her liner serial # is part of the recall.Patient has not been revised to date.Patient was last known to be in stable condition.The device is not available for evaluation.No additional information.
Additional Manufacturer Narrative
Concomitant products: truliant cr cem fem cr cem right sz 3 (cat# 02-020-13-0330 / serial# (b)(4)); truliant tib fit tray cem sz 3f / 3t (cat# 02-022-45-3030 / serial# (b)(4)); advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(4)); collar fixation pin 2pk 40mm, quick release (cat# 201-78-82 / serial# (b)(4)).As reported, this 74 y/o female patient called to confirm if her liner was part of the recall.She states she has had pain and swelling in her knee for several years and was told by her surgeon her knee is fine and there is nothing else he can do for her.She was also upset her surgeon did not notify her about the recall and was told by his office her knee was not part of the recall."she no longer can drive due to the revised knee".Her liner serial # is part of the recall.Patient has not been revised to date.Patient was last known to be in stable condition.The device is not available for evaluation.No additional information.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 knee pain cannot be conclusively determined; however, it is most likely related to patent underlying conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Pain is a known risk of joint replacement surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 problem code.This follow-up report is being submitted to relay additional information.The following sections were updated: a2 date of birth.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The joint swelling and pain reported cannot be confirmed and contributions from patient, user, or device related considerations to the event could not be assessed because the devices remain implanted, and relevant patient information, clinical information and/or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 3, 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16070796
• Report Number: 1038671-2022-01643
• Device Sequence Number: 6294906
• Product Code: JWH
• UDI-Device Identifier: 10885862230416
• UDI-Public: 10885862230416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

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: 06/13/2025
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3, 11MM
• Device Catalogue Number: 02-012-51-3011
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 02/05/2025; 04/16/2025
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 03/05/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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: 73 YR
• Patient Sex: Female