MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 5
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: logic tibia ps mod insrt sz 5 11mm (cat# 02-012-35-5011 / serial# (b)(4), lgc tibial fit tray cem sz 5f / 5t (cat# 02-012-45-5050 / serial# (b)(4), fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(4), tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4).As reported by the legal brief, on (b)(6) 2018, a male patient underwent a right tkr, over time, the patient began experiencing pain, swelling, instability, and an inability to bear weight on his right knee.¿eventually, the symptoms became so severe that he was having significant difficulty ambulating.¿ on (b)(6) 2020, patient underwent revision.¿during the revision procedure, patient¿s surgeon noted defective equipment requiring complete revision.¿ no additional information.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 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.
Event or Problem Description
As reported by the legal brief, on (b)(6) 2018, a male patient underwent a right tkr, over time, the patient began experiencing pain, swelling, instability, and an inability to bear weight on his right knee.¿eventually, the symptoms became so severe that he was having significant difficulty ambulating.¿ on (b)(6) 2020, patient underwent revision.¿during the revision procedure, patient¿s surgeon noted defective equipment requiring complete revision.¿ no additional information.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the reason for the revision cannot be confirmed from the information provided but may be due to a combination of prosthesis wear and aseptic loosening between the femoral component and the bone as reported or may have been the result of patient conditions, implant sizing, or implant positioning issues.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.A contributing factor to the alleged wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for five years.However, the reported loosening and wear could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with the event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8: e (correcting initial report), g2, h6: clinical codes, component code, medical device problem code, investigation findings, investigation conclusion.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2026-00233.The reason for the revision cannot be confirmed from the information provided but may be due to a combination of prosthesis wear and aseptic loosening between the femoral component and the bone as reported or may have been the result of patient conditions, implant sizing, or implant positioning issues.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.A contributing factor to the alleged wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for five years.However, the reported loosening and wear could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Report # 1 of 2 for this event.It was reported via legal documentation a patient had an initial right total knee arthroplasty.Subsequently, two (2) years later, the patient experienced pain, swelling, instability, bone loss, aseptic (non-infected) loosening and ambulation difficulties.As a result, the patient underwent a revision procedure of the femoral and tibial insert components.No further patient impact was reported.No additional information is available.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 5
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16092587
• Report Number: 1038671-2023-00005
• Device Sequence Number: 6529248
• Product Code: JWH
• UDI-Device Identifier: 10885862314581
• UDI-Public: 10885862314581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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 PS CEM FEM PS CEM RIGHT SZ 5
• Device Catalogue Number: 02-020-11-0350
• 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: 09/18/2023; 02/25/2026
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 10/23/2023; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male