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

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	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products: truliant tib imp ps insert sz 4.5 11mm (cat# 02-022-35-4511 / serial# (b)(4)).Truliant ps cem fem ps cem right sz 4.5 (cat# 02-020-11-0345 / serial# (b)(4)).Truliant tib imp ps insert sz 4.5 11mm (cat# 02-022-35-4511 / serial# (b)(4)).Truliant tib fit tray cem sz 4.5f/3.5t (cat# 02-022-45-4535/ serial# (b)(4)).Advanced patella 35mm 3 peg implant (cat# 200-07-35 / serial# (b)(4)).
Event or Problem Description
As reported, approximately 2.5 years postop, this (b)(6) y/o male patient had a revision done based on right femur being loose.The doctor advised rep of this revision.Patient was last known to be in stable condition following the event.The device is not available for evaluation as hospital retains all retrievals.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The most probable root cause for the reported event of "loosening - femoral" is associated with weakened integration of the femoral component 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
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11398999
• Report Number: 1038671-2021-00080
• Device Sequence Number: 1164995
• Product Code: JWH
• UDI-Device Identifier: 10885862314574
• UDI-Public: 10885862314574
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 65 YR