MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Insufficient Information (4580); Joint effusion (4849)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 101-05-20 - 3.2mm drill bit 20mm 1pk.(b)(6), 164-13-10 - novation element ro s/o col sz 10.(b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6), 186-01-52 - integrip cc, cluster 52mm, g2.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement on (b)(6) 2016.Approximately 6 years and 2 months after the initial procedure the patient had a left hip revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
As a result of additional information received, the following fields have been updated: a2, a3, b5, and h6.Further information and/or investigation results will be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation the patient had a left hip replacement on (b)(6) 2016 due to advanced arthritis.Approximately 6 years and 2 months after the initial procedure the patient had a left hip revision on (b)(6) 2023.Revision op report noted that the stem appeared to be very well fixed.The removed polyethylene insert showed significant wear.The report further noted that the patient had moderate osteolysis superiorly and posteriorly and significant thinning of the medial wall.They were taken to the recovery room in satisfactory condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
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 corrected information.The following sections were corrected: b1, b2, g4, h6 - health effect - clinical code, component code, type of investigation, investigation findings, h7, h9 and h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.The patient 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 lateralized liner.A definitive root cause was unable to be determined; however, may have resulted from 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).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, +5LAT, 36MM G2-52/54MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 3523771140
• MDR Report Key: 17672670
• Report Number: 1038671-2023-02135
• Device Sequence Number: 5981301
• Product Code: JDI
• UDI-Device Identifier: 10885862024329
• UDI-Public: 10885862024329
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 08/28/2021
• Device Model Number: NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
• Device Catalogue Number: 136-36-52
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 04/02/2024; 04/22/2026
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/26/2023; 04/11/2024; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• 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-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female