MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Joint effusion (4849)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related: mfr #1038671-2022-01574 report 1 of 2.H11.Additional manufacturer narrative- report 2 of 2.D10.Concomitant products: logic stem ext 14mm x 25mm (cat# 02-012-60-1425 / serial#(b)(6).Truliant tib fit tray cem sz 3f / 3t (cat# 02-022-45-3030 / serial#(b)(6).Advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(6).Truliant ps cem fem ps cem right sz 3 (cat# 02-020-11-0330/ (b)(6).Tibial stem ext.Screw (cat# 204-70-00/ sn (b)(6).These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately 3 years, 7 months post initial tka, patient had a revision due to polyethylene wear and femoral loosening.Additional information received from legal brief indicates that following the surgery, patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.Patient¿s physician discussed with patient his concerns regarding early oxidation of her recalled exactech polyethylene insert and suspected femoral loosening.Patient was diagnosed with ¿failed total right knee replacement¿ secondary to her recalled truliant device and was informed of her need for a full revision surgery.Patient was scheduled for a right knee replacement revision surgery and then rescheduled.Per the event information provided the revision occurred.There is no additional information available.
Additional Manufacturer Narrative
D10 concomitant products: - logic stem ext 14mm x 25mm (cat# 02-012-60-1425 / serial# (b)(6)) - truliant tib imp ps insert sz 3 9mm (cat# 02-022-35-3009 / serial# (b)(6)) k152170 - truliant tib fit tray cem sz 3f / 3t (cat# 02-022-45-3030 / serial# (b)(6)) - advanced patella 32mm 3 peg implant (cat# 200-07-32 / serial# (b)(6)) -tibial stem ext.Screw (cat# 204-70-00/ sn (b)(6)).H6: corrected the following: type of investigation, investigation findings, investigation conclusions.The revision reported was likely the result of prosthesis wear and femoral loosening, as stated in the legal documentation and clinical study.The extent of the reported prosthesis wear cannot be determined as the devices were not available for evaluation and images of the explanted devices, pre-revision radiographs, and operative notes were unable to be obtained.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.It is unclear if the reported prosthesis wear may have contributed to the reported femoral loosening or if the femoral loosening contributed to the reported prosthesis wear.

• Brand Name: TRULIANT
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19818934
• Report Number: 1038671-2024-02503
• Device Sequence Number: 8671178
• Product Code: JWH
• UDI-Device Identifier: 10885862304254
• UDI-Public: 10885862304254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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
• Report Date (Section B): 10/09/2024

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 Catalogue Number: 02-022-35-3009
• 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: 11/20/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 115 KG
• Patient Race: Black Or African American