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

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, surgeon revised a truliant femur implanted in (b)(6) 2019 at university (b)(6).The femur was subsided and was explanted without cement on the backside.The surgeon mentioned this in the or.Surgeon implanted a cc femur with ps bearing and 5mm distal augment.Patient should recover well after revision knee.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d10, g3, g7 and h2 have been updated accordingly.Section d10: concomitant medical products truliant tib imp ps insert sz 4 9mm (cat# 02-022-35-4009 / serial# (b)(6)).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, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of an insufficient bony support for the implant, loosening of the femoral component, poor bone quality, or any combination of the three.However, this cannot be confirmed as the device was not available for evaluation.Additionally, no details regarding the cement used or the cement technique were provided and their contributions to the reported event cannot be determined.The most probable root cause associated with the reported event of "subsidance/migration" is a problem with all or part of an implanted device moving from its intended location in the body.

• Brand Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12130768
• Report Number: 1038671-2021-00327
• Device Sequence Number: 14559111
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• Combination Product (Y/N): N
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2021

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
• Device Catalogue Number: 02-020-11-0340
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 09/13/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/29/2021; 10/12/2021
• 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