MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	130-36-54
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Distress (2329); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitants: 4118946 - 164-01-12 - element-stem, collarless w/ha, std offset, sz 12 4487770 - 170-36-07 - biolox delta femoral head 36mm od, +7mm 4414694 - 186-03-60 - integrip mh cup sz 60mm.These devices are used for treatments, not diagnosis.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016, and then experienced revision surgical procedure on (b)(6) 2023 approximately 6 years and 9 months after initial implant.No images were provided.There is no other information 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.H6: corrected health effect and investigation clinical codes.
Additional Manufacturer Narrative
H6: corrected health effect - clinical code.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19170986
• Report Number: 1038671-2024-00961
• Device Sequence Number: 7949194
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 10/08/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Catalogue Number: 130-36-54
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 08/27/2024; 09/19/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/09/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown