MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; SEE H10

Catalog Number	130-28-51
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.H6 investigation results - connexion gxl devices, all serial numbers are affected by recall; specific devices were no provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.No other information is available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial left hip arthroplasty on (b)(6) 2017 and then approximately 5 years, 7 months later, on (b)(6) 2022, the patient experienced a revision surgery.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
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, 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 cause for the reported revision due to prosthesis wear and osteolysis may have been 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 as the devices were not returned for evaluation, and images and radiographs were not provided.G4: corrected h6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 17053399
• Report Number: 1038671-2023-01226
• Device Sequence Number: 20579023
• Product Code: LZO
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: Not provided; 01/30/2025
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 09/06/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown