MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0215
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 10000219053 a10012 - gps implant kit v2 (b)(4).02-012-60-1425 - tru stem ext 14mm x 25mm (b)(4).02-020-11-0215 - truliant ps cem fem ps cem left sz 1.5 (b)(4).02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t (b)(4).200-02-29 - three peg patella 29mm 6172608.204-70-00 - tibial stem ext.Screw.The product associated with the reported event is within the scope of recall [enter recall #]; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (mdl no.(b)(4)).Patient id: (b)(6).Related (b)(4).As reported via legal documentation the patient had a left knee replacement on (b)(6) 2019.Approximately 3 years and 2 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 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.02-022-35-1509 - truliant tib imp ps insert sz 1.5, 9mm.Sn: (b)(6).Concomitant devices: (b)(4) a10012 - gps implant kit v2.(b)(4) 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(4) 02-020-11-0215 - truliant ps cem fem ps cem left sz 1.5.(b)(4) 02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t.(b)(4) 200-02-29 - three peg patella 29mm.(b)(4) 204-70-00 - tibial stem ext.Screw.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.(b)(4), and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature 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.(b)(6) 2024 investigation summary: the reason for the revision reported in (b)(4) 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 manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, g4, h6.Mdr section codes updated/corrected: b, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of 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 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 PS CEM FEM PS CEM LEFT SZ 1.5
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20332542
• Report Number: 1038671-2024-03732
• Device Sequence Number: 15487862
• Product Code: JWH
• UDI-Device Identifier: 10885862314406
• UDI-Public: 10885862314406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 02-020-11-0215
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 06/18/2019
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown