MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
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 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, 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.
Event or Problem Description
As reported, approximately 3 months post initial left total hip arthroplasty (tha), the patient underwent revision as the poly was worn and needed replacing.During the revision, it was determined that the cup also needed to be removed due to bone void.The patient was revised to competitor acetabular components and the surgeon implanted the exactech biolox delta option 28mm head and +0 adapter because the stem stayed intact.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitants: 120-65-40 - bone screw 6.5mm dia x 40mm long (b)(6).142-36-00 - cocr fem head 36mm +0 offset 12/14 (b)(6).160-31-11 - pf spline plasma w/ha ext offset sz 11 (b)(6).180-01-52 - nv crown cup clstr hole 52mm group 2 (b)(6).

• Brand Name: NV GXL LNR, +5LAT, 36MM G2-52/54MM 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20792110
• Report Number: 1038671-2024-04525
• Device Sequence Number: 7809021
• Product Code: JDI
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 11/29/2014
• Device Catalogue Number: 136-36-52
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2010
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female