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

Model Number	COCR FEM HEAD 28MM +3.5 OFFSET 12/14
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial left side tha, this female patient was brought back with left hip pain and signs of osteolysis.The femoral head was removed, the stem was well fixed, the acetabular liner was removed with the use of a bone screw, the cup was checked and found to be well fixed.A new g 0 28mm lipped xle liner was implanted.A new femoral head was placed and hip was reduced.There was no breakage to device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays attached.The devices will be return.
Additional Manufacturer Narrative
Concomitant medical products: gxl nuetral liner, g0 28mm id (cat# 130-28-50 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section h10: (h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified: significant edge loading of the femoral head on the acetabular liner due to acetabular component positioning and combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors specified.
Event or Problem Description
Revision op report received via the legal department- revision left hip procedure on (b)(6) 2022.Pre & post operative diagnosis: failed total hip arthroplasty surgery performed: left hip revision arthroplasty of the acetabular and femoral component.The surgeon noticed significant acetabular wear and cystic changes in the acetabulum.The patient tolerated the procedure well with no complications.She was taken back to the postanesthesia recovery room in stable fashion with successful left anterior hip revision arthroplasty of both the acetabular and femoral components.There is no other information available.
Additional Manufacturer Narrative
Additional information- b5.
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: a, d, g.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors for gxl: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13623402
• Report Number: 1038671-2022-00226
• Device Sequence Number: 5269598
• Product Code: JDI
• UDI-Device Identifier: 10885862022059
• UDI-Public: 10885862022059
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2025

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: 10/10/2020
• Device Model Number: COCR FEM HEAD 28MM +3.5 OFFSET 12/14
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 07/19/2023; 07/23/2025
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 07/11/2022; 07/19/2023; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female