MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-32-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteolysis (2377); Insufficient Information (4580)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient underwent a revision of their hip liner.No further information available at this time.
Additional Manufacturer Narrative
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 review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was 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
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6) 180-01-58 - crown cup, cluster-hole gr.58.This follow-up report is being submitted to relay additional and corrected information.
Event or Problem Description
As part of the manufacturer's recall, the patient presented for a follow-up.X-ray and cat scans revealed significant decentration of the prosthetic head and unusually large osteolytic lesions in the acetabulum, indicating inlay wear.This was verified during an inlay exchange to a specially approved, vit e-cured inlay.During the exchange surgery, in addition to the inlay exchange, the firm integrity of the cup was determined, and the cysts in the cup bed were cured and sealed using hydroxyapatite + calcium (bone void filler), as well as the replacement of the prosthetic head.

• Brand Name: NV GXL LNR, +5 LAT 32MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21813853
• Report Number: 1038671-2025-01791
• Device Sequence Number: 15305848
• Product Code: JDI
• UDI-Device Identifier: 10885862024299
• UDI-Public: 10885862024299
• 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: 2016
• 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
• Report Date (Section B): 07/07/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2018
• Device Catalogue Number: 136-32-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 06/13/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 04/30/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• 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: Hospitalization
• Patient Sex: Male