MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; ASY HI-FLEX PS CEM FEM, SZ 4, LEFT

Model Number	244-02-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/06/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the united kingdom national joint registry (uknjr).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by united kingdom national joint registry (uknjr), this (b)(6) y/o, (bmi=(b)(6)) male patient underwent primary total prosthetic replacement using cement of the l knee via medial parapatellar approach on (b)(6) 2009.The indication for the index procedure was osteoarthritis.The patient was implanted with a optetrak hi-flex cemt fem comp asymmetric size 4 left (catalog 244-02-04, serial (b)(4)), optetrak rbk cemt finned tibial tray 4f/5t (catalog 260-04-45, serial (b)(4)), optetrak posterior stabilised rbk tib insert size 4 9mm (catalog 264=24-09, serial (b)(4)), and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2015, approximately 73 months post implantation, the patient underwent revision due to infection.The exactech were removed and replaced.
Additional Manufacturer Narrative
(h3) the evaluation noted that the revision reported as reported by united kingdom national joint registry (uknjr), this 59 y/o, (bmi=0), male patient underwent primary total prosthetic replacement using cement of the l knee via medial parapatellar approach on (b)(6) 2009.The indication for the index procedure was osteoarthritis.The patient was implanted with a optetrak hi-flex cemt fem comp asymmetric size 4 left (catalog 244-02-04, serial (b)(6)), optetrak rbk cemt finned tibial tray 4f/5t (catalog 260-04-45, serial (b)(6)), optetrak posterior stabilised rbk tib insert size 4 9mm (catalog 264=24-09, serial (b)(6)), and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(6)).Based on review of all available information, there is no evidence to suggest that the reported event is related to any device design or manufacturing issues.The event reported was likely the result of patient conditions.There has been no patient medical history/information provided; therefore, the patient risk/clinical factors cannot be assessed.
Event or Problem Description
As reported by united kingdom national joint registry (uknjr), this 59 y/o, (bmi=0), male patient underwent primary total prosthetic replacement using cement of the l knee via medial parapatellar approach on (b)(6) 2009.The indication for the index procedure was osteoarthritis.The patient was implanted with a optetrak hi-flex cemt fem comp asymmetric size 4 left (catalog 244-02-04, serial (b)(6)), optetrak rbk cemt finned tibial tray 4f/5t (catalog 260-04-45, serial (b)(6)), optetrak posterior stabilised rbk tib insert size 4 9mm (catalog 264=24-09, serial (b)(6)), and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(6)).On (b)(6) 2015, approximately 73 months post implantation, the patient underwent revision due to infection.The exactech were removed and replaced.

• Brand Name: OPTETRAK
• Common Device Name: ASY HI-FLEX PS CEM FEM, SZ 4, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9699470
• Report Number: 1038671-2020-00059
• Device Sequence Number: 1877826
• Product Code: JWH
• UDI-Device Identifier: 10885862063793
• UDI-Public: 10885862063793
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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 Expiration Date: 10/16/2013
• Device Model Number: 244-02-04
• Device Catalogue Number: 244-02-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/26/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR