MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Model Number	NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377); Implant Pain (4561)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 1341747; 180-01-60 - nv crown cup clstr hole 60mm group 4, 2307472; 164-02-11 - element-stem, collarless w/ha, high offset, sz 11, 2371127; 170-36-00 - biolox delta femoral head 36mm od, +0mm, pending investigation.
Event or Problem Description
As reported via legal documentation a 55 y/o male patient had a left hip replacement on (b)(6) 2012.Approximately 10 years and 1 month after the initial procedure the patient had a left hip revision on (b)(6) 2022 due to pain.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.Revision op report on (b)(6) 2022; diagnosis: failed left hip; patient was developing extensive osteolysis and pain in his hip with activity.During the procedure it was noted to have significant scarring.Sterile dressings applied and the patient was taken to recovery room in satisfactory condition.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of osteolysis and an insufficient bond between the femoral stem and the bone, which led to aseptic (non-infected) femoral loosening.The extent and root cause of the osteolysis and loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is 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) and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.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 G4-60/62MM 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17108039
• Report Number: 1038671-2023-01319
• Device Sequence Number: 6346209
• Product Code: LZO
• UDI-Device Identifier: 10885862024343
• UDI-Public: 10885862024343
• 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: 2012
• Device Explanted Year: 2022
• 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): 05/06/2025
• 2 Devices were Involved in the Event: 1 2

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: 08/07/2017
• Device Model Number: NV GXL LNR, +5LAT, 36MM G4-60/62MM CUPS
• Device Catalogue Number: 136-36-54
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/20/2023; 05/05/2025
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 12/08/2023; 12/20/2023; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2010
• 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: K070479
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male