MAUDE Adverse Event Report: EXACTECH, INC. NOVATION CFS CEM, STD, SIZE 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION CFS CEM, STD, SIZE 12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: femoral head (cat# 142-28-93).Femoral head (cat# 150-042).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the (b)(6) study, approximately twenty-three days post ltha, the (b)(6) y/o female patient was hospitalized due to detection of a collection of fluid compatible with an abscess in mri two weeks after surgery.Resolved with antibiotic treatment.Patient discharged after 2 weeks.The clinical study reported the event is not related to the device but possibly related to the procedure.Devices remain implanted.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech hip replacement study, approximately twenty-three days post ltha, the 83 y/o female patient was hospitalized due to detection of a collection of fluid compatible with an abscess in mri two weeks after surgery.Resolved with antibiotic treatment.Patient discharged after 2 weeks.The clinical study reported the event is not related to the device but possibly related to the procedure.Devices remain implanted.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent antibiotic treatment cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: NOVATION CFS CEM, STD, SIZE 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12089222
• Report Number: 1038671-2021-00319
• Device Sequence Number: 11600071
• Product Code: JDI
• UDI-Device Identifier: 10885862036278
• UDI-Public: 10885862036278
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K090764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: NOVATION CFS CEM, STD, SIZE 12
• Device Catalogue Number: 168-50-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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
• Patient Age: 83 YR