MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-51-4509
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op the initial tka, this male patient was revised.Patient presented clinic with pain and requesting recalled insert be removed.Surgeon performed a poly exchange.He noted significant synovitis.He removed osteophytes around the patella.He stated the insert was not worn significantly.Explants not available without patient release.No further information available.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 02-020-13-0345 - truliant cr cem fem cr cem right sz 4.5, 5382374, 02-022-45-4535 - truliant tib fit tray cem sz 4.5f/3.5t, 5472550, 200-02-35 - three peg patella 35mm, 5495866, 521-78-23 - threaded pin size 2.3 collared 2pk, s004066, a10012 - gps implant kit v2 06021018250.
Additional Manufacturer Narrative
Section h10: (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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 4 years post op the initial tka, this male patient was revised.The patient presented to the clinic with pain and requesting that the recalled insert be removed.The surgeon performed a poly exchange.The surgeon noted significant synovitis and removed osteophytes around the patella.The surgeon stated that the insert was not worn significantly.Explants are not available without patient release.No further information is available from the representative.
Event or Problem Description
As reported, approximately 4 years post op the initial tka, this male patient was revised.The patient presented to the clinic with pain and requesting that the recalled insert be removed.The surgeon performed a poly exchange.The surgeon noted significant synovitis and removed osteophytes around the patella.The surgeon stated that the insert was not worn significantly.Explants are not available without patient release.No further information is available from the representative.
Event or Problem Description
It was reported via legal documentation that the patient has filed a short-form complaint.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of their polyethylene device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6 -clinical code - failure of implant no longer applies, problem code, component code results of the investigation will be reported within 30 days of completion.
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: b, c, d, e.The revision reported may have been due to prosthesis wear and/or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information 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 CRC INSERT SZ 4.5, 9MM
• 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: 15454492
• Report Number: 1038671-2022-01139
• Device Sequence Number: 12481135
• Product Code: JWH
• UDI-Device Identifier: 10885862307811
• UDI-Public: 10885862307811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2026
• Device Model Number: 02-022-51-4509
• Device Catalogue Number: 02-022-51-4509
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 07/30/2024; 07/09/2025
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/08/2022; 12/30/2024; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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 Sex: Male