MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS; HIP ACETABULAR COMPONENTS

Model Number	NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient had a left hip revision due to loosening.All components were removed and replaced with competitor's device.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays received.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d6a, d9, d10, g3, g4, g6, h2, h3, h4, h7 and h9 have been updated accordingly.Section d10: concomitant products element-stem, collared w/ha, std offset, sz 12 (cat# 164-03-12 / serial# (b)(6)) alteon 6.5mm screw, 20mm (cat# 180-65-20 / serial# (b)(6)) alteon 6.5mm screw, 20mm (cat# 180-65-20 / serial# (b)(6)) integrip cc, cluster 58mm, g3 (cat# 186-01-58 / serial# (b)(6)) cocr femoral head 40mm, +3.5 offset 12/14 (cat# 142-40-03 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of insufficient bond between the femoral stem and the bone and patient-related conditions, which led to aseptic (non-infected) femoral stem loosening.The most probable root cause associated with the reported event of ¿loosening¿ is associated with weakened integration of the femoral stem at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
• Common Device Name: HIP ACETABULAR COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14644059
• Report Number: 1038671-2022-00657
• Device Sequence Number: 5756770
• Product Code: LPH
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2019
• Device Model Number: NOVATION GXL LNR +5 LAT 40MM GROUP 3 CUPS
• Device Catalogue Number: 136-40-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 02/14/2023
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 11/10/2022; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown