MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial tha, patient was revised due to pain and wear per surgeon.Patient was revised with same sizes but with vit e poly.There was no breakage or surgery delay was noted.Patient had good range of motion (rom) and stability.Patient left in stable condition.The devices are not available for evaluation.No further information available.
Additional Manufacturer Narrative
Concomitant medical products: 4.5mm drill bit 30mm (cat#: 101-45-30 / serial#: (b)(4); biolox delta femoral head 32mm od, +3.5mm (cat#: 170-32-03 / serial#: (b)(4); alteon 6.5mm screw, 20mm (cat#: 180-65-20 / serial#: (b)(4); integrip cc, cluster 50mm, g1 (cat#: 186-01-50 / serial#: (b)(4); wedge plasma x/o sz 7 (cat#: 188-01-07 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Based on the available information, the revision reported may have been the result of pain and a combination of the 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 but not limited to the combination of largest available femoral head and/or thinnest available acetabular liner.However, the photographed acetabular liner and radiograph do not show signs of wear that are inconsistent with being implanted for approximately 6 years.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected:b1, d8 e4 (remove erroneous entry from initial report), h6 clinical codes, component code, types of investigation, investigation findings and investigation conclusions.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 32MM ID, GROUP 1 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: kate jacobdson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15877690
• Report Number: 1038671-2022-01519
• Device Sequence Number: 17504303
• Product Code: JDI
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 09/19/2021
• Device Model Number: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 05/01/2023; 04/16/2026
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 05/30/2023; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female