MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/08/2024
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 4.5 years post initial tha, the 77 y/o female patient had revision due to polyethylene wear.The patient was revised to a cc inlay vitamin e, lateralise, ø 32, gr.1 (cat# 146-32-51 / serial# (b)(6) no further information at this time.
Additional Manufacturer Narrative
(h3) a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified, 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 both patient-related conditions and the risk 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 devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.
Additional Manufacturer Narrative
Additional information: h6 - component coding.Corrected data: d4 - exp date/serial #.H4 - mfg date.H6 - health effect / clinical coding.H6 - investigation findings coding.H6 - investigation conclusion coding.

• Brand Name: NV GXL LNR, +5LAT, 32MM G1-48/50MM 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: michael crader
• MDR Report Key: 18831207
• Report Number: 1038671-2024-00383
• Device Sequence Number: 7879005
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
• Device Catalogue Number: 136-32-51
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 04/12/2024; 09/06/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/24/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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 Age: 77 YR
• Patient Sex: Female