MAUDE Adverse Event Report: EXACTECH, INC. NOVATION HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately one month post initial left side tha, patient had a revision for an unknown reason.The representative has no knowledge of this case from 2016.No additional information available.
Additional Manufacturer Narrative
Concomitant medical products: biolox delta femoral head 40mm 0d, +3.5mm (cat# 170-40-03 / serial#: (b)(4).Device evaluated by mfr: as reported, approximately one month post initial left side total hip arthroplasty, patient had a revision for an unknown reason.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, reason not reported.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: d1, d4 (remove all from initial report-suspect device unknown), d8, e4 (remove entry from initial report), g4 (remove 501k from initial report-unknown), h4 (remove date from initial report-unknown), h6 clinical code, medical device code, component code, investigation conclusions.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NOVATION HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 jacobsom ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15834121
• Report Number: 1038671-2022-01490
• Device Sequence Number: 14800500
• Product Code: JDI
• UDI-Device Identifier: 10885862220301
• UDI-Public: 10885862220301
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 05/16/2018
• Device Model Number: NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
• Device Catalogue Number: 136-40-53
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1732-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown