MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-2013
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-61-4000 - logic offset stem ext coupler 4mm, (b)(6) 02-012-60-1212 - logic stem ext 12mm x 120mm, (b)(6) 201-78-25 - small headed sharp pin, 1 1/8" 4 pack, (b)(6) 02-012-60-1412 - logic stem ext 14mm x 120mm, (b)(6) 208-05-02 - cc distal fem augment sz 2, 5mm, (b)(6) 208-05-02 - cc distal fem augment sz 2, 5mm, (b)(6) 02-010-06-0220 - logic cc femoral size 2, left, (b)(6) 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t.
Event or Problem Description
Approximately two-year post initial left side tka, the 86 y/o female patient had a revision.Preoperative diagnosis-failed left knee arthroplasty due to instability, poor motion, pain and patellar component loosening.Patient was revised to same company devices.The femoral component rotation was okay, matching the epicondylar axis.There was dense scar throughout the knee in extension with medial liftoff of 5mm with valgus stress.Both the femoral and tibial components appeared to be appropriately sized and in appropriate rotation.There was no evidence of loosening of either the femoral or tibial components.The joint fluid was clear and yellow.There was no evidence of deep infection.The patient was awakened and transferred to the recovery room in stable condition.There were no intraoperative complications.There is no other information available.Right knee revision reported under mdr # 1038671-2023-00338.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b, c, d, e the reason for the revision reported cannot be confirmed from the information provided but may be the result of patellar loosening, prosthesis wear, instability, and loss of range of motion.The reported patellar loosening, prosthesis wear, instability, and loss of range of motion could not be confirmed.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and full product information 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: TRU CC TIB INSERT SIZE 2, 13MM
• 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; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21019644
• Report Number: 1038671-2024-05000
• Device Sequence Number: 9207405
• Product Code: JWH
• UDI-Device Identifier: 10885862613318
• UDI-Public: 10885862613318
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2025
• Device Catalogue Number: 02-012-65-2013
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female