MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4), category #: 200-07-29 - advanced patella 29m 3 peg implant.Serial #: (b)(4), category #: 02-012-60-1425 - logic stem ext 14mm x 25mm.Serial #: (b)(4), category #: 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.Serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw.Serial #: (b)(4), category #: 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.Additional information including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Legal case prose (b)(6).Related case: (b)(4).Per a report from the legal department the patient had a right knee replacement on (b)(6) 2019.Approximately 2 years 4 months post initial surgery the patient had a right knee revision.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Serial #: (b)(4), category #: 02-022-35-2511 - truliant tib imp ps insert sz 2.5 11mm, the serial number (b)(4), is not affected by the recall.510k: k152170.Concomitants: serial #: (b)(4), category #: 200-07-29 - advanced patella 29m 3 peg implant.Serial #: (b)(4), category #: 02-012-60-1425 - logic stem ext 14mm x 25mm.Serial #: (b)(4), category #: 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.Serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw.Serial #: (b)(4), category #: 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.
Event or Problem Description
It was reported via legal documentation that the patient had a left total knee arthroplasty on (b)(6) 2019.It is stated that the patient has suffered and continues to suffer permanent, and debilitating injures and damages, including but not limited to significant pain and discomfort, swelling, stiffness, grinding and/or popping of the knee, inability to bear weight, buckling, gait impairment, and other injuries presently undiagnosed, which all require ongoing medical care, and that the patient requires revision surgery.There is no other patient demographic or medical history available.No additional information is available.
Additional Manufacturer Narrative
Additional information- b7, d8, h6.Health effect - clinical code-pain.Health effect - impact code- stated to be pending revision surgical procedure.H6.Investigation results- the truliant tib imp ps insert device with serial number (b)(6) is not affected by the fda recall.The cause of the patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition 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.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.There is no other information available.Correction-, b3, b5-this patient was not revised, d6b- this patient was not revised, f10-blank, this is a manufacturer¿s report, h6 health effect - impact code-this patient was not revised.
Event or Problem Description
It was reported via legal documentation that approximately 72 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, pain and discomfort, swelling, stiffness, grinding and/or popping of the knee, inability to bear weight, buckling, and gait impairment.Initial surgery operative notes were provided.At the time of legal notification, no revision procedure had been performed.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Additional information fields: a2, b2, b5, g, g2, g3, h6-clinical codes.Corrected fileds: b3(delete date-no event), d6b (delete-no event), e1, h6 impact code, medical device program code, component code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided, but may have been due to prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and 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: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16742796
• Report Number: 1038671-2023-00696
• Device Sequence Number: 17501621
• Product Code: JWH
• UDI-Device Identifier: 10885862304186
• UDI-Public: 10885862304186
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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 Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
• Device Catalogue Number: 02-022-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 06/08/2023; 03/25/2025
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/10/2023; 03/11/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female