MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp crc insert sz 2.5, 15mm (cat # 02-022-51-2515 / serial# (b)(4)), truliant tib fit tray cem sz 2.5f / 2.5t (cat # 02-022-45-2525 / cat # 6758300).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by (b)(6) study, approximately three months post right tka, patient has increased pain and swelling when bending knee.A joint aspiration done, synovial fluid analysis was performed and labs show positive for persistent infection (continued chronic prosthetic joint infection).Surgeon performed a revision surgery on (b)(6) 2021 with removal of implants, placement of spacer, and implanted remedy manufacturer components.Patient has been started on 6-weeks iv antibiotics.The event is unlikely related to the device but related to the procedure.
Additional Manufacturer Narrative
After further review of additional information.(h3) as reported by the exactech truliant knee clinical study, approximately three months post right tka, patient has increased pain and swelling when bending knee.A joint aspiration done, synovial fluid analysis was performed and labs show positive for persistent infection (continued chronic prosthetic joint infection).Surgeon performed a revision surgery on (b)(6) 2021 with removal of implants, placement of spacer, and implanted remedy manufacturer components.Patient has been started on 6-weeks iv antibiotics.The event is unlikely related to the device but related to the procedure.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient conditions, which caused the infection.

• Brand Name: TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5
• 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: 13426437
• Report Number: 1038671-2022-00144
• Device Sequence Number: 5303767
• Product Code: JWH
• UDI-Device Identifier: 10885862315311
• UDI-Public: 10885862315311
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-020-13-0325
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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 Sex: Unknown