MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported via legal notification that the patient had an initial primary right knee total arthroplasty surgery 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.Additional information received -it was reported that the patient has complained of pain.The patient had a revision surgical procedure on (b)(6) 2023 for a loose femur and recalled poly approximately 3 years, 4 months after implant.The patient was revised to exactech devices.Reported event is not related to breakage of a device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays were provided.Product not returning: chain of command.Due to recall hospital will not release.There is no additional information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 5362405 02-022-35-4013 - truliant tib imp ps insert sz 4 13mm-fda recall z-0023-2022.6378786 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.6384282 200-07-35 - advanced patella 35mm 3 peg implant.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-04813 this follow-up report is being submitted to relay additional and/or corrected information.D10: concomitants: (b)(6) 02-020-11-0340 - truliant ps cem fem ps cem right sz 4.(b)(6) 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.(b)(6) 200-07-35 - advanced patella 35mm 3 peg implant.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04813.The following sections were updated: g1, h6.The following sections were corrected: b1, b2, d2b, d4, d6a, d6b, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear 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 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.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
• 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: 17857300
• Report Number: 1038671-2023-02429
• Device Sequence Number: 6759124
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 01/20/2023
• Device Catalogue Number: 02-020-11-0340
• 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
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male