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

Model Number	NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products - 4.5mm drill bit 40mm (cat# 101-45-40 / serious# (b)(6)) - p-series pf plasma collarless sz 6 12/14 (cat# 118-01-06 / serious# (b)(6)) - nv gxl liner lipped 40mm id, group 4 cups (cat# 132-40-54 / serious# (b)(6)) - biolox delta femoral head 40mm od, -3.5mm (cat# 170-40-93 / serious# (b)(6)) - nv crown cup clstr hole 62mm group 4 (cat# 180-01-62 / serial# (b)(6)) - alteon 6.5mm screw, 30mm (cat# 180-65-30 / serious# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eight years post initial tha, the male patient was revised due to pain.Osteolysis was noted on ct and x-ray.Bone grafting and cement was used in the bone loss areas.Competitor's dual mobility cup was cemented inside the novation cup and new exactech head was used.There was no issues with surgery.X-rays and photo attached.Explants not available for evaluation.No further information available.
Additional Manufacturer Narrative
The patient/gxl acetabular liner involved was reportedly revised due to prosthesis wear and osteolysis approximately 7 years and 9 months after the index surgery.The revised components were not returned to exactech for evaluation.However, images and radiographs of removed liners/implants were provided.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1 b2 d10 concomitant devices: 4143043 101-45-40 - 4.5mm drill bit 40mm, 2038797 118-01-06 - p-series pf plasma collarless sz 6 12/14, 2585520 132-40-54 - nv gxl liner lipped 40mm id, group 4 cups, 2599363 170-40-93 - biolox delta femoral head 40mm od, -3.5mm, 4066764 180-01-62 - nv crown cup clstr hole 62mm group 4, 4157507 180-65-30 - alteon 6.5mm screw, 30mm.The patient/gxl acetabular liner involved in incident was reportedly revised due to prosthesis wear and osteolysis approximately 7 years and 9 months after the index surgery.The revised components were not returned to exactech for evaluation.However, images and radiographs of removed liners/implants were provided.Based on the available information, the patient involved in incident meets the following risk criteria for early prosthesis wear: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear 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).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.

• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17786300
• Report Number: 1038671-2023-02334
• Device Sequence Number: 6253224
• 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: 2015
• Device Explanted Year: 2023
• 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): 12/02/2024

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: 01/24/2018
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS
• Device Catalogue Number: 132-40-54
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/29/2024; 11/18/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 05/09/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2013
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male