MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 2F/1T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CEMENTED FINNED TIB. TRA SZ 2F/1T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products : three peg patella 29mm (cat# 200-02-29).Ps tibial inserts sz 1, 9mm (cat# 204-21-09).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 14 yrs postop the initial rtka, the female patient had her tibia revised due to loosening.The patient received a new truliant revision tibia size 1, 10 x80 blasted stem, 10 mm tibial augments and a size 11 insert.Patient was last known to be in stable condition following the event.The device will not be returned due to hospital discarded the implants.
Additional Manufacturer Narrative
H3: the evaluation noted that revision reported was likely the result of an insufficient bond between the implant and the bone after 14 years of implantation which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "loosening - tibial" 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: CEMENTED FINNED TIB. TRA SZ 2F/1T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12073183
• Report Number: 1038671-2021-00312
• Device Sequence Number: 17144936
• Product Code: JWH
• UDI-Device Identifier: 10885862039699
• UDI-Public: 10885862039699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 08/03/2021

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: CEMENTED FINNED TIB. TRA SZ 2F/1T
• Device Catalogue Number: 200-04-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/27/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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