MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 36MM ID GROUP 2
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial tha, the male patient was revised due to pain.Poly wear was noted by surgeon.A new vit e liner and ceramic head were implanted.There was no issues with surgery.Photos received.The devices are not available for evaluation.
Additional Manufacturer Narrative
Section d10: concomitant products.Biolox delta femoral head 36mm od, +0mm (cat# 170-36-00 / serial# (b)(6).Alteon 6.5mm screw, 30mm (cat# 180-65-30 / serial# (b)(6).Integrip cc, cluster 54mm, g2 (cat# 186-01-54 / serial# (b)(6).Wedge plasma x/o sz 10 (cat# 188-01-10 / seral# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3.Investigation results- based on the available information, the patient involved meets risk criteria for early prosthesis wear -combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e1, e2, e3, g2, h6.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• 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: matt collins
• MDR Report Key: 18395188
• Report Number: 1038671-2023-03055
• Device Sequence Number: 18280047
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: 02/04/2023
• Device Model Number: NV GXL LINER LIPPED 36MM ID GROUP 2
• Device Catalogue Number: 132-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 04/15/2024; 04/24/2026
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 04/18/2024; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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: Required Intervention
• Patient Sex: Unknown