MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5508940, 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.5523747, 02-020-11-0230 - truliant ps cem fem ps cem left sz 3.5550008, 02-012-60-1425 - tru stem ext 14mm x 25mm.5558951, 204-70-00 - tibial stem ext.Screw.5611571, 200-07-32 - advanced patella 32mm 3 peg implant.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2018.Approximately 4 years and 5 months after the initial procedure the patient had a left knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on 31 mar 2023 diagnosis: failed left total knee arthroplasty secondary to polyethylene wear from a recalled tibial insert and aseptic loosening of the femoral component."there was synovitis with evidence of polyethylene debris in the gutters.I released soft tissue sleeve off the proximal medial tibia.I then brought the knee into extension.I debrided the synovial tissue and the polyethylene synovitis using bovie cautery and a rongeur.I then cleared off the scar tissue from around the patellar button.There was some damage to this as well.I therefore decided to exchange it.The previous tibial insert was removed with a 1/2-inch osteotome.On gross inspection, there were no obvious wear, there was a little bit of pitting in the articular surface.I then used the disimpactor, i was able to disimpact the femoral component fairly easily.There was no attachment to the bone cement.The patient was awoken from anesthesia and transferred to the recovery room in stable condition.".
Additional Manufacturer Narrative
Recall number: z-0023-2022.1038671-2024-04822, 1038671-2024-04820 this follow-up report is being submitted to relay additional and/or corrected information.D10: concomitants: (b)(6) 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.(b)(6) 02-020-11-0230 - truliant ps cem fem ps cem left sz 3.(b)(6) 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 200-07-32 - advanced patella 32mm 3 peg implant.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04822, 1038671-2024-04820.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, and/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 images and radiographs 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 PS INSERT SZ 3 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18310110
• Report Number: 1038671-2023-02960
• Device Sequence Number: 6643951
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Expiration Date: 11/09/2025
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Unknown