MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4011
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Distress (2329); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, this male patient is approximately 2 yrs postop l tka, is now scheduled for a liner replacement on (b)(6) 2023, due to the recall from exactech.No other information is available at this time.
Additional Manufacturer Narrative
Section h10: (d1) brand name: truliant tib imp ps insert sz 4 11mm.(d4) catalog number: 02-022-35-4011, serial number: (b)(6), expiration date: 07-jul-2028, unique identifier (udi) #: (b)(4).(d10) concomitant device(s): (b)(6).02-012-60-1425 - logic stem ext 14mm x 25mm, (b)(6).02-020-11-0240 - truliant ps cem fem ps cem left sz 4, (b)(6).02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t, (b)(6).200-02-35 - three peg patella 35mm, (b)(6).204-70-00 - tibial stem ext.Screw, (b)(6).A10012 - gps implant kit v2.(g4) pma/510(k)number: k152170.(h3) 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, insufficient information.These devices are used for treatment not diagnosis.(h4) device manufacture date: 16-jul-2020.(h7) recall.(h9) z-0023-2022.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of polyethylene wear and osteolysis as stated in the operative notes.The extent and root cause of the polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and radiographs or photographs were not provided.
Event or Problem Description
Additional information via legal department: revision operative report of (b)(6) 2023 for failed left total knee polyethylene due to wear and recall with osteolysis of the femoral component.Operative findings: there was a clean wound with clear synovial joint fluid.There was visible and palpable wear of the tibial polyethylene with reaction of the synovium due to poly wear.A complete synovectomy was performed.There were well-fixed tibial and patellar components.There was no evidence of any infection.There was mild osteolysis behind the cement mantle of the distal femur.Dressing was applied with compression wrap.The patient was awakened and transferred to recovery in stable condition, there were no complications.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
The new information will require a new investigation.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.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 4 11MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16096072
• Report Number: 1038671-2023-00013
• Device Sequence Number: 15116309
• Product Code: JWH
• UDI-Device Identifier: 10885862304452
• UDI-Public: 10885862304452
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/17/2025

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 Catalogue Number: 02-022-35-4011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 05/24/2023; 09/18/2023; 03/14/2025
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/19/2023; 06/20/2023; 09/22/2023; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female