MAUDE Adverse Event Report: EXACTECH, INC. MCS GXL LINER 5/15 DEG 5052X28; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	104-28-44
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 100-28-00, 3622012 - cocr femoral head 28mm +0mm neck.
Event or Problem Description
As reported, approximately 5.5 years post op the initial tha, this female patient was revised.Patient was having issues so the surgeon swapped out the head and liner for a new ones.The liner was moving within the cup.Devices will not be returning, hospital kept.
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, b, c, d, e, g d6b: date is unknown.The revision reported may be due to the liner becoming loose in the cup as reported.However, the device-device loosening, contributing factors, sequence of events, and user or patient related factors cannot be confirmed from the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: MCS GXL LINER 5/15 DEG 5052X28
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15503212
• Report Number: 1038671-2022-01186
• Device Sequence Number: 17446261
• Product Code: JDI
• UDI-Device Identifier: 10885862013507
• UDI-Public: 10885862013507
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 06/04/2019
• Device Model Number: 104-28-44
• Device Catalogue Number: 104-28-44
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2014
• 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-1728-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female