MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.5 years post initial bilateral tka, the 55 y/o female patient complained of pain.Patient had a left knee revision due to recalled poly and loose femur.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due to hospital will not release recalled implants.
Additional Manufacturer Narrative
Section d10: concomitant products - truliant tib fit tray cem sz 3f / 2t (cat# 02-022-45-3020 / serial# (b)(6).- truliant tib imp ps insert sz 3 9mm (cat# 02-022-35-3009 / serial# (b)(6).- advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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 revisions reported was likely the result of insufficient bonds between the femoral components and the bones and/or patient related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation.The most probable root cause associated with the reported event of ¿loosening - femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
Report number: 1038671-2024-05005 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8 g1 h6 the following sections were corrected: b2 h6 the reason for the revisions reported cannot be confirmed from the information provided but may be the result of femoral loosening and 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17585723
• Report Number: 1038671-2023-01990
• Device Sequence Number: 3626592
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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 LEFT SZ 3
• Device Catalogue Number: 02-020-11-0230
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 12/26/2024
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/23/2023; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female