MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: conconmitants: (b)(6), 170-36-03 biolox delta femoral head 36mm od, +3.5mm.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 186-01-58 - integrip cc, cluster 58mm, g3.(b)(6), 188-01-07 - wedge plasma x/o sz 7.(b)(6), 188-01-10 - wedge plasma x/o sz 10.
Event or Problem Description
It was reported that a 53 yo male patient, initial left hip implanted in (b)(6) 2014, underwent a revision procedure in (b)(6) 2024, approximately 10 years 1 month post the initial implant.The patient presented back to the surgeon¿s off with complaints of their tha, including pain, stiffness, and dissatisfaction.The patient has a recalled hip polyethylene liner, which was worn out on the x-ray.The patient was scheduled for a tha revision on (b)(6)2024, during which the patient underwent a poly acetabular liner swap and femoral head swap.The liner was changed from a neutral style to a +5 lateralized component and the femoral head length was increased.There were no device breakages during the procedure.There was a 15-30 minute surgical delay during the procedure with no impact to the patient.They addressed an extensive bone/osteophyte and scar tissue growth around the acetabular cup that took extra time to resect and clear.Also the first replacement acetabular liner would not lock in properly and was wasted.The acetabular rim was cleared again and a second poly liner was opened and implanted.The second implant did lock in properly.X-rays were provided.The patient left the or stable.The explanted devices are not available for return.They were discarded by the facility.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d.The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The most likely underlying cause for the reported revision is due to the complaints of pain.Prosthesis wear of the acetabular liner could not be confirmed from the provided device images and radiographs, the devices did not meet any of the 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 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 LINR, NTRL, 36MM ID, GROUP 3 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; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21150883
• Report Number: 1038671-2025-00245
• Device Sequence Number: 9135082
• Product Code: JDI
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 130-36-53
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male