MAUDE Adverse Event Report: EXACTECH, INC. GXL NUETRAL LINER, G0 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-28-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices.142-28-00 - cocr fem head 28mm +0 offset 12/14 2560674.142-28-93 - cocr fem head 28mm -3.5 offset 12/14 2529963.164-01-11 - element-stem, collarless w/ha, std offset, sz 11 2347968.180-01-46 - cup, cluster-hole, 46mm group 0 2266797.H3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.
Event or Problem Description
The patient has filed a short-form complaint in a coordinated action in alachua county with master case no.(b)(4).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, e.The most likely cause for the reported revision due to prosthesis wear is 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 as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: GXL NUETRAL LINER, G0 28MM ID
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19191899
• Report Number: 1038671-2024-00992
• Device Sequence Number: 8361488
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 07/14/2014
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2010
• 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: Z-1731-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown