MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-32-51
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Discomfort (2330); Osteolysis (2377); Insufficient Information (4580)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a patient, who had a hip implanted, was revised to a 140-32-51 cc inlay vitamin e neutral, ø 32, gr.1 b135501.No further information known at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, osteolysis, loosening, infection, fracture, instability/dislocation, leg length discrepancy, and/or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: d1, d4, d6a, g1, h4, h6: type of investigation.The most likely cause for the revision reported is prosthesis wear and osteolysis due to a combination 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).However, this cannot be confirmed because the devices were not available for evaluation and no images or radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b2, b3, b4, b7, d4, d6a, d6b, d10, h6, h11.D10: 180-01-48 - crown cup, cluster-hole gr.48 (b)(6).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As part of the manufacturer's recall, the patient presented for a follow-up examination due to increasing discomfort/pain in her thigh.X-ray and ct scans revealed significant decentering of the prosthetic head and unusually large osteolytic lesions in the acetabulum, indicative of inlay wear.This was addressed during an inlay replacement procedure using a specially approved vitamin e-reinforced inlay.(xle, neutral liner, group 1, 32 mm).The findings were verified.During the revision surgery, in addition to replacing the inlay, the integrity of the acetabular socket was confirmed, the cysts in the acetabular bed were curetted and filled with hydroxylapatite + calcium (cerament bone void filler), and the prosthetic head was replaced.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 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: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 22155205
• Report Number: 1038671-2025-02241
• Device Sequence Number: 7292459
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

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: 10/05/2021
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 12/22/2025; 02/27/2026
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/11/2025; 01/14/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• 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; Hospitalization
• Patient Sex: Female