MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 1.Novation acetabular cup, catalog no.180-01-60, lot no.2530980; 2.Novation femoral stem, catalog no.160-33-16, lot no.2973169; and 3.Femoral head, catalog no.142-36-00, lot no.2996947.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that a patient had an initial left total hip replacement on (b)(6) 2014.Following a period of post-implantation recovery and for years after the replacement surgery, the patient¿s exactech hip device performed as expected.The patient underwent revision of the exactech hip device secondary to significant polyethylene liner wear resulting in synovitis and osteolysis on (b)(6) 2020, approximately 5 years 7 months post the initial procedure.Despite undergoing the revision surgery, the patient experiences daily hip pain and discomfort which limit activities of daily living and recreation and impacts quality of life.The patient has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; metallosis; soft tissue damage; infection; and other injuries presently undiagnosed, which all require ongoing medical care.The patient has sustained and will sustain future damages, including but not limited to additional revision surgeries; cost of medical care; rehabilitation; home health care; loss of earning capacity; mental and emotional distress; and pain and suffering.No device returns anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: based on the available information, the patient involved in this case meets the following risk criteria for early prosthesis wear as specified in the hhe: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to prosthesis wear is a combination of the risk factors specified.However, this cannot be confirmed because the device was not available for evaluation and images were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2: d.O.B., b1, b2, b3, d1, e3, g2 (correct initial report), h6: clinical codes, component code, investigation findings, 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 LNR, LIPPED, 36MM 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: 16585442
• Report Number: 1038671-2023-00473
• Device Sequence Number: 17330503
• Product Code: JDI
• UDI-Device Identifier: 10885862023438
• UDI-Public: 10885862023438
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 10/28/2017
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS
• Device Catalogue Number: 132-36-54
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 04/13/2023; 01/14/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/08/2023; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• 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-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male