MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3510
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa *original description summary* as reported via legal documentation the patient had a left knee replacement on (b)(6) 2017.Approximately 2 years and 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2020.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Ebi initial surgery attached.Historical record and smartsolve searched for sn/patient name with no results.Unable to determine right and left products.The patient has filed a complaint in a coordinated action in alachua county with master case no.2022 ca 002670.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.As directed by qa management: this legal complaint for polyethylene issues occurred in the us.The event did not occur in, nor is it reportable for australia, brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.*additional information received from legal on 12sep2023* as reported via legal documentation the patient had a left knee replacement on (b)(6) 2017.Approximately 2 years and 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2020.Revision op report postoperative diagnosis: aseptic loosening, left femur and patella.There was some erosion under the medial aspect of the patella and it was loose.The femoral component was checked by tapping on the anterior flange and it came loose from the cement.Cement mantle was intact.The well-fixed tibial component was removed with minimal additional bone loss.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.
Additional Manufacturer Narrative
1038671-2023-02331 1038671-2024-04207 d10: concomitant devices truliant femoral component (02-020-11-0235, (b)(6) truliant fit tibial tray (02-022-45-3535, (b)(6) optetrak 3 peg patella (200-07-32, (b)(6).Manufacturer narrative: the reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure, femoral loosening and patellar loosening could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 10MM
• 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 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20587502
• Report Number: 1038671-2024-04208
• Device Sequence Number: 21031974
• Product Code: JWH
• UDI-Device Identifier: 10885862304353
• UDI-Public: 10885862304353
• 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: 2017
• Device Explanted Year: 2020
• 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): 11/01/2024

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: 09/08/2025
• Device Catalogue Number: 02-022-35-3510
• 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: 07/31/2023
• Initial Report FDA Received Date: 11/01/2024
• Date Device Manufactured: 09/13/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female