MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Anxiety (2328); Ambulation or Postural Difficulties (2544)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - logic stem ext 14mm x 25mm (cat# 02-012-60-1425 / serial# (b)(6).- truliant tib imp ps insert sz 3.5 9mm (cat# 02-022-35-3509 / serial# (b)(6).- recall device - z-0023-2022)).- truliant tib fit tray cem sz 3.5f / 2.5t (cat# 02-022-45-3525 / serial# (b)(6).- fluted headless pin 3.0" square head, pk2 (cat# 02-029-99-1001 / serial# (b)(6).- threaded head pin 2.3" square head, pk2 (cat# 02-029-99-1002 / serial# (b)(6).- advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(6).- tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by legal brief, despite experiencing continuous pain and instability in her right knee, patient was forced to schedule a total replacement surgery for her left knee at the advice of her surgeon.The surgery to implant the exactech total knee replacement system was performed on (b)(6), 2021.Patient again underwent extensive physical rehabilitation in the months following her second total knee replacement surgery and continued to experience extensive pain and instability, particularly in her right knee.On (b)(6) 2022, patient received a phone call from her surgeon who explained that both of her total knee replacements systems were recalled and informed her that both of her knees would need to be replaced again.Patient received a letter from the southern joint replacement institute on (b)(6), 2022, which provided written notice that she received defective parts from an exactech knee replacement system and that the components were being recalled.Additional information received indicates that the 51 y/o female patient complained of pain.Patient had a revision due to loose femur and recalled poly.Due to recall surgeon used competitors for revision.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are not available for evaluation due hospital will not release recall implants.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the 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
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision 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 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 PS CEM FEM PS CEM LEFT SZ 3.5
• 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 ; 3523771140
• MDR Report Key: 17734036
• Report Number: 1038671-2023-02251
• Device Sequence Number: 14908046
• Product Code: JWH
• UDI-Device Identifier: 10885862314444
• UDI-Public: 10885862314444
• 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: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2025

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 PS CEM FEM PS CEM LEFT SZ 3.5
• Device Catalogue Number: 02-020-11-0235
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 01/21/2025; 02/26/2025
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 12/18/2023; 01/22/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female