MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 1.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 1.5, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants products: truliant cr cemented femur right size 1.5 (cat# 02-020-13-0315 / serial# (b)(4)).Truliant cemented tibial tray size 1.5f/1.5t (cat# 02-020-45-1515 / serial# (b)(4)).Optetrak 3 peg patella size 32mm round (cat# 200-02-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.5 years post initial right tka, this (b)(6) male patient's surgeon booked a revision tka with patellectomy.The patient had a fall on their total knee and post the fall the patient was having pain and instability.The poly implant that was in the patient and removed during the revision surgery was affected by the exactech manufacturer knee poly recall.The surgeon went from what was in an 11 mm crc to trailing and implanting a 15 mm crc poly.The surgeon removed bone from the patella and closed the knee.The patient left the or stable.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos & x-rays received.The devices are not available for evaluation as the devices were discarded or lost in transit from the sx room to decontamination and spd.
Additional Manufacturer Narrative
(h3) as reported, approximately 3.5 years post initial right tka, this 75 y/o male patient's surgeon booked a revision tka with patellectomy.The patient had a fall on their total knee and post the fall the patient was having pain and instability.The poly implant that was in the patient and removed during the revision surgery was affected by the exactech manufacturer knee poly recall.The surgeon went from what was in an 11 mm crc to trailing and implanting a 15 mm crc poly.The surgeon removed bone from the patella and closed the knee.The patient left the or stable.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos & x-rays received.The devices are not available for evaluation as the devices were discarded or lost in transit from the operating room to decontamination and spd.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 revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and a trauma.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 1.5, 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: 14279475
• Report Number: 1038671-2022-00516
• Device Sequence Number: 6256502
• Product Code: JWH
• UDI-Device Identifier: 10885862307460
• UDI-Public: 10885862307460
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 09/14/2025
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 1.5, 11MM
• Device Catalogue Number: 02-022-51-1511
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• 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-0019 THRU 0027-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female