MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department the patient had a hip replacement on (b)(6) 2020.Approximately 1 year and 3 months after the initial procedure the patient had a hip revision on (b)(6) 2021.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical product: (b)(6) 101-45-20 - 4.5mm drill bit 20mm, (b)(6) 122-65-20 - 6.5mm acetabular bone screw 20mm, (b)(6) 164-03-10 - element-stem, collared w/ha, std offset, sz 10, (b)(6) 170-36-00 - biolox delta femoral head 36mm od, +0mm, (b)(6) 180-01-58 - nv crown cup clstr hole 58mm group 3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is prosthesis wear and acetabular loosening and a combination of risk factors specified: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16834147
• Report Number: 1038671-2023-00862
• Device Sequence Number: 11582292
• Product Code: JDI
• UDI-Device Identifier: 10885862220301
• UDI-Public: 10885862220301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 04/03/2023
• Device Model Number: NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
• Device Catalogue Number: 136-40-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male