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

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 62 yo female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 3 years 9 months post the initial procedure due to complaints of stiffness in their left knee.The patient presented with decreased flexion.Under anesthesia, the surgeon assessed the rom.A synovectomy was performed around all the implants.The implant was removed using an osteotome.The original poly showed no obvious issues or abnormalities.The original poly was tight within the knee joint and took multiple instruments to remove.The surgeon continued performing a synovectomy and used a cobb to perform minor releases within the joint.The surgeon then used a logic style sz 2.5 - 9mm poly trail to trail through a rom with a thinner option than what was in there, to begin with.The surgeon used a mallet on the poly handle to help get the trail inserted into the tibia tray.Once the trail was inserted the knee was taken through a rom.The 9mm was decided on, as it helped increase flexion and still kept stability.The surgeon requested for a non-recalled size 9mm for the 2.5 femur to be opened.The knee joint and surrounding wound was irrigated well.The new 9mm ps poly implant for the sz 2.5 was implanted into the knee and a final rom was performed.The surgeon was satisfied.The surgeon does not believe the patient's complaints and presented issues are due to the poly recall.The patient left the or stable.The device is available for return.
Additional Manufacturer Narrative
Concomitants: 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5 (b)(4), 02-022-35-2511 - truliant tib imp ps insert sz 2.5 11mm (b)(4), 02-022-45-2515 - truliant tib fit tray cem sz 2.5f / 1.5t (b)(4), 200-02-32 - three peg patella 32mm (b)(4), additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: 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.
Event or Problem Description
No additional information.

• Brand Name: TRULIANT
• 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 ; 3523771140
• MDR Report Key: 15629048
• Report Number: 1038671-2022-01327
• Device Sequence Number: 5983110
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 08/23/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Device Catalogue Number: 02-022-35-2511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female