MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2017
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post op the initial tka, this 86 y/o female patient was revised due pain.Recalled poly and patella exchange.This is patient's second revision on this knee.
Additional Manufacturer Narrative
Pending manufacturer evaluation.Concomitant device(s): (b)(4) - 200-07-32 - advanced patella 32mm 3 peg implant; (b)(4) - 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack; (b)(4) - 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
Additional information - b1, b5, b7, d8, & h6 medical device problem code pending investigation.
Event or Problem Description
Additional information received via legal-revision operative report for failed left total knee arthroplasty due to polyethylene wear secondary to the recall; on 14 feb 2023.Findings: the patella demonstrated a lateral and polyethylene wear with an area of delamination.The component was not loose.The tibial side demonstrated generalized, but symmetric tibial poly wear.There was wear particularly in the posterior aspect of the post.The polyethylene, the patellar component had an area approximately 5x7 mm in the lateral facet where the polyethylene was delaminated.The patellar component was not loose.The tibial component demonstrated symmetrical wear both medial and laterally with some discoloration of the polyethylene.There was a significant posterior post-polyethylene wear.There were no areas of delamination.The area of lysis was confined to the anterior cortex of the femur just proximal to the flange.The components were carefully inspected and were not loose and the overall positioning was good.There as a dense scar throughout the knee and a synovectomy was performed.Light compression dressing was applied.The patient was then awakened and transferred to the recovery room in stable condition.There were no intraoperative complications.There is no other patient demographic or medical history available.There is no device return.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2 17MM
• 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 ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16478048
• Report Number: 1038671-2023-00338
• Device Sequence Number: 19614618
• Product Code: JWH
• UDI-Device Identifier: 10885862304148
• UDI-Public: 10885862304148
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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: 09/18/2025
• Device Catalogue Number: 02-022-35-2017
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 12/16/2024
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/27/2023; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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
• Patient Age: 86 YR
• Patient Sex: Female