MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: truliant 3.5/2.5 fit tray (cat# 02-022-45-3525 / serial# (b)(4)).3.5 12mm psc insert (cat# 02-022-44-3512 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.5 years postop the initial ltka, the (b)(6) female patient¿s femur and tibia were both revised due to loosening.The liner was removed, tibia found to be loose and removed, femur was checked and found to be loose as well.The patient received a logic cck knee system.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of patient-related conditions and an insufficient bond between the implants and the bones, which led to aseptic (non-infected) femoral and tibial loosening and tibial tray subsidence.However, this cannot be confirmed as the devices and immediate post-operative x-rays of the initial surgery were not available for evaluation.The most probable root cause associated with the reported event of "loosening¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root cause associated with ¿tibial subsidence¿ is associated with a tibial tray that subsides into the prepared tibia further than expected.This typically occurs post-operatively.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12362574
• Report Number: 1038671-2021-00416
• Device Sequence Number: 14408334
• Product Code: JWH
• UDI-Device Identifier: 10885862314444
• UDI-Public: 10885862314444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5
• Device Catalogue Number: 02-020-11-0235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female