MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five months post initial rtka, the (b)(6) y/o male patient had a revision due to a loose tibia and femur.After trialing the femoral component, the surgical team could not match the definitive components to match stem position of the trial, when all setting were mimicked.The 4mm offset bushing of the trial was in position 9, which surgeon selected during case.Later trials were built and 4mm trial femoral bushing was set to 9.Trialing was completed and surgeon instructed us to build final implants.When we built femur with 4mm bushing set to 9 final femur did not look like the trial components.Both were 4mm bushings set to 9 and stem position was completely different.After much discussion and analysis from surgeon and our sales team we decided to reposition bushing until it replicated the trial implant.This exercise caused us to move from 9 to somewhere between 5-6.It almost seemed like the laser etchings were mal positioned.Component was cemented and implanted successfully, and knee was very stable.Below we attached dgf of implants but we are not sure which 4mm bushing was the problematic one.Patient was last known to be in stable condition following the event.The device will not be returned for analysis due to hospital policy.
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp psc insert sz 4.5, 12mm, cat# 02-022-44-4512, serial# (b)(4), truliant tib fit tray cem sz 4.5f/4.5t, cat# 02-022-45-4545, serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of an insufficient bond between the implants and the bones, which led to aseptic (non-infected) femoral and tibial loosening.However, this cannot be confirmed as the explants were not available for evaluation and x-rays were not provided.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.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
• 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: 12771523
• Report Number: 1038671-2021-00592
• Device Sequence Number: 3144673
• Product Code: JWH
• UDI-Device Identifier: 10885862314574
• UDI-Public: 10885862314574
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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 RIGHT SZ 4.5
• Device Catalogue Number: 02-020-11-0345
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 04/19/2022
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male