MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 150-07-17 - modular straight stem 13mm x 200mm 1486245, 150-25-01 - modular small meta 25mm 1556745, 122-65-40 - 6.5mm acetabular bone screw 40mm 1654171, 122-65-25 - 6.5mm acetabular bone screw 25mm 1654281, 158-02-01 - 12/14 lpb m-series neck hi offset +0 1827043, 180-01-58 - nv crown cup clstr hole 58mm group 3 1832781, 148-36-00 - 12/14 zirconia head 36mm rep by 170-36-00 1860242.
Event or Problem Description
Email to complaints usa.Hip revision.Patient id: (b)(6).It was reported that this patient's hip will be revised.At this time plan is for head and liner exchange with poly wear.Acetabular cyst present, no further information at this time.Hi dr.(b)(6), i hope you are well.I am reaching out regarding an upcoming hip revision with exactech implants scheduled on oct 22.I am your rep for the case.Can you please provide me patient name and dob so i can acquire implant.Good morning, patient in question is (b)(6), (b)(6)1963.At this time plan is for head and liner exchange with poly wear.Acetabular cyst present so chance we have to revise acetabular component and will plan on removing acetabular screws at the very least.Appreciate your assistance with this case.Sincerely, (b)(6).130-36-53 nv gxl linr, ntrl, 36mm id, group 3 cups 1814297.Udi number (b)(4).510(k) number k070479.Product code jdi, lph, lwj, lzo, meh.Recall number z-1729-2022.Concomitants: 150-07-17 - modular straight stem 13mm x 200mm 1486245, 150-25-01 - modular small meta 25mm 1556745, 122-65-40 - 6.5mm acetabular bone screw 40mm 1654171, 122-65-25 - 6.5mm acetabular bone screw 25mm 1654281, 158-02-01 - 12/14 lpb m-series neck hi offset +0 1827043, 180-01-58 - nv crown cup clstr hole 58mm group 3 1832781, 148-36-00 - 12/14 zirconia head 36mm rep by 170-36-00 1860242.No further information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d4, d6b, g4, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The reported prosthesis wear could be confirmed from the provided radiograph.The most likely underlying cause for the revision reported is 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) and being implanted for more than 10 years.However, the potential root cause 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: NV GXL LINR, NTRL, 36MM ID, 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
• MDR Report Key: 20553359
• Report Number: 1038671-2024-04156
• Device Sequence Number: 8979879
• Product Code: JDI
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2014
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2010
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown