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

Model Number	GXL NUETRAL LINER, G0 28MM ID
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, the female patient underwent a left total hip arthroplasty surgical procedure on (b)(6) 2013.Patient had a revision surgery performed on (b)(6) 2020 due to "catastrophic poly wear" and "metallosis.".
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d10, g3, g4, g6, h2, h3, h4, h6, h7 and h9 have been updated accordingly.Section d10: concomitant product - 12/14 zirconia head 28mm +0mm neck (cat# 148-28-00 / serial# (b)(6)) (h3) based on the available information, the revision reported may have been the result of a combination of the risk factors including but not limited to use error, implant positioning, implant size selection, and patient factors, which led to polyethylene wear, metallosis, and osteolysis.However, this cannot be confirmed as the devices, radiographs, and operative notes were not provided.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14781731
• Report Number: 1038671-2022-00710
• Device Sequence Number: 6108473
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 11/29/2017
• Device Model Number: GXL NUETRAL LINER, G0 28MM ID
• Device Catalogue Number: 130-28-50
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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: Female