MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number TRULIANT TIB IMP PS INSERT SZ 3 9MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 12/20/2017

Event Type  Injury  

Event Description

It was reported via an exactech truliant knee clinical study, that a 69 yo male patient, initial left knee implanted on (b)(6) 2017, was seen on (b)(6) 2017, regarding severe pain and a hematoma formation.He had not been able to regain his rom.His knee has remained very stiff and painful.Mua and removal of knee scar tissue considered if necessary.Continued physical therapy, use of dynasplint, daily mobic use with protonix indicated.The patient was given compression stockings to help with swelling.Ultrasound performed.No deep vein thrombosis found.He did have resolving hematoma.Range of motion exam and knee manipulation under anesthesia was performed on (b)(6) 2018.The study indicates the event is unlikely related to device, but possibly related to procedure.Outcome indicates resolved on (b)(6) 2018.No further information.

Manufacturer Narrative

Concomitants: 4828350, catalog #: 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, 4976624, catalog #: 521-78-23 - threaded pin size 2.3 collared 2pk, 4977050, catalog #: 02-020-11-0230 - truliant ps cem fem ps cem left sz 3, 5021286, catalog #: 201-78-15 - holding pin mini sharp point 4 pk, 5037852, catalog #: 200-02-35 - three peg patella 35mm, 5081054, catalog #: 521-78-32 - threaded pin size 3.0 collarless 2pk based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and activity.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT
• Type of Device: 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 ; 3523771140
• MDR Report Key: 16274702
• MDR Text Key: 308522972
• Report Number: 1038671-2023-00089
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862304254
• UDI-Public: 10885862304254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/31/2023

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
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 3 9MM
• Device Catalogue Number: 02-022-35-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/31/2023
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0023-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 95 KG