MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-40-54
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): serial #: (b)(4), category #: 186-01-60 - integrip cc, cluster 60mm, g4, serial #: (b)(4), category #: 180-65-40 - alteon 6.5mm screw, 40mm, serial #: (b)(4), category #: 180-65-25 - alteon 6.5mm screw, 25mm, serial #: (b)(4), category #: 170-40-93 - biolox delta femoral head 40mm od, -3.5mm, serial #: (b)(4), category #: 180-65-35 - alteon 6.5mm screw, 35mm, serial #: (b)(4), category #: 180-65-30 - alteon 6.5mm screw, 30mm, serial #: (b)(4), category #: 180-65-30 - alteon 6.5mm screw, 30mm.
Event or Problem Description
As reported by legal, approximately 4 years post op the initial left tha, this 61 y/o male patient was revised.Patient had pain due to hip joint prosthesis.No further information available.
Additional Manufacturer Narrative
H11.Updated/additional information ¿ d8.G1.G2.G4.H6.The most likely cause for the revision reported due to prosthesis wear 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 not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported may have been the result of prosthesis wear, osteolysis, acetabular cup loosening, and bone screw loosening as reported in the operative notes.The prosthesis wear may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) acetabular loosening may have been the result of an insufficient bond between the acetabular cup and the bone, and the screw loosening may be secondary to the reported osteolysis.Additional contributing factors to the reported failures may have been the result of a combination of the 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 as the devices were not available for evaluation, and images and radiographs were not provided at the time of this 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 LINER LIPPED 40MM ID, GROUP 4 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16700411
• Report Number: 1038671-2023-00610
• Device Sequence Number: 5617159
• Product Code: JDI
• UDI-Device Identifier: 10885862207050
• UDI-Public: 10885862207050
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: 11/08/2022
• Device Catalogue Number: 132-40-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/03/2024; 02/10/2025
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/04/2024; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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
• Patient Age: 61 YR
• Patient Sex: Male