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	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530); Bone Shedding Debris (4557)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately three years post initial left tha, the (b)(6) male patient had a revision due to lots of wear on poly and patient had metallosis all over his hip.There was no parts or pieces fell into the patient wound site.There was a 45 minutes surgical delayed but there was no adverse event as a result of the surgical delay/prolongation.Patient was revised to xle poly.Sales rep was unable to obtain x-rays/photos.The device will be return.
Additional Manufacturer Narrative
(h3) the patient/gxl acetabular liner involved was reportedly revised due to early prosthesis wear and metallosis approximately three years after the index surgery.However, the revised components were not returned to exactech for evaluation and no images or radiographs were provided.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than two years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.Section d1:brand name section d4: model number, catalog number, unique identifier (udi) # section d10: device available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
It was reported via legal documentation that approximately 36 months after a left total hip replacement, the patient underwent left hip revision to address prosthesis wear.A post operative op report was provided.Post op diagnosis noted chronically failed total hip arthroplasty due to polyethylene wear.Intraoperatively, the surgeon observed metallosis and synovitis and fragmented polyethylene liner pieces in the joint causing the metallosis.Additionally, the surgeon observed a linear scratch on the surface of the femoral head.Both liner and femoral head components were replaced.It was noted that the patient's weight contributed to a more complex approach and positioning difficulties, intraoperatively.No surgical or medical interventions were reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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 fracture and a combination of risk factors: 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14308039
• Report Number: 1038671-2022-00533
• Device Sequence Number: 5273728
• Product Code: JDI
• UDI-Device Identifier: 10885862220301
• UDI-Public: 10885862220301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/28/2025

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?: 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 06/07/2023; 09/04/2024; 04/25/2025
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/27/2023; 02/19/2025; 04/28/2025
• 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: ALTEON 6.5MM SCREW, 20MM (2); ALTEON 6.5MM SCREW, 30MM; BIOLOX DELTA FEMORAL 40MM OD, +0MM; INTEGRIP MH CUP SZ 58MM; WEDGE PLASMA X/O SZ 11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male