MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately two years post initial tha, patient had a revision due to polyethylene wear.Patient was revised to a cc inlay vitamin e, lippe ø 32, gr.2 (cat# 142-32-62 / serial# (b)(6)).The device is not available for evaluation.No additional information available.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, implanted with a lateralized liner and implanted with a component having a shelf age of greater than two years.The revision reported was likely the result of a combination of the 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 confirmed as the device(s) were not available for evaluation and images of the explanted devices/pre-revision radiographs were not provided.
Additional Manufacturer Narrative
After further review of additional information received the following sections a3, b5, b7, g3, g6 and h2 have been updated accordingly.Section b5: additional information received indicates that in the case of complaints in the left artificial hip joint implanted in 2020 without trauma a radiological check was carried out.A considerable decentration for 2 years after implantation was impressive of the head in the inlay with osteolysis of the socket interface as a sign of significant inlay wear.This could be verified during an inlay change on 06-sep-2022 to a vitd-hardened specially approved inlay.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: NV GXL LNR, +5LAT, 32MM 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17019630
• Report Number: 1038671-2023-01167
• Device Sequence Number: 7125874
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2026

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: 06/20/2023
• Device Model Number: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 07/13/2023; 09/19/2026
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/06/2023; 08/09/2023; 09/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• 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: Female