MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: truliant ps por fem ps por right sz 4.5(cat#02-020-12-0345((b)(6)).Truliant tib imp ps insert sz 4.5 9mm(cat#02-022-35-4509((b)(6)).Advanced patella 32mm 3 peg implant(cat#200-07-32((b)(6)).H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01346, 1038671-2026-00193.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.Review of the non-conforming reporting database and/or device history record can be conducted to look for manufacturing-related issues including but not limited to dimensional non-conformities or issues with the material that may have caused or contributed to the reported event.If an issue is found during the review, escalation may be required, which could result in a product recall.The tibial insert manufacturing lot involved in this case has already been recalled from the field due to the non-conforming product packaging detailed above.Therefore, additional manufacturing review has been deemed unnecessary and will not be conducted at this time.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, prosthesis wear, and femoral loosening 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, radiographs, 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.
Event or Problem Description
Report #3 of 3 for this event.It was reported a patient had an initial right total knee arthroplasty.Subsequently, a few weeks later, the patient experienced pain.One (1) year, five (5) months later, the patient reports pain and dissatisfaction with implant function.As a result, the patient underwent a right knee revision procedure due to loose tibia.It was noted the tibia was loose with only fibrous ingrowth and the femur had minimal bone ingrowth.The patient was last known to be in stable condition following the event.Additionally, it was reported via legal documentation the patient has suffered severe pain and loss of mobility due to prosthesis wear.No additional information is available.510k; k171045 concomitant products: - truliant ps por fem ps por right sz 4.5(cat#02-020-12-0345/serial# 5758187) - truliant tib imp ps insert sz 4.5 9mm(cat#02-022-35-4509/serial# 5316760) - advanced patella 32mm 3 peg implant(cat#200-07-32/serial# 6857967).

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 25027585
• Report Number: 1038671-2026-00513
• Device Sequence Number: 9175582
• Product Code: JWH
• UDI-Device Identifier: 10885862304520
• UDI-Public: 10885862304520
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 03/06/2026
• Device Catalogue Number: 02-022-35-4509
• 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: 08/22/2023
• Initial Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 03/07/2018
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female