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

Device Problem Device-Device Incompatibility (2919)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation: concomitant device(s): 100-28-00, 3622012 - cocr femoral head 28mm +0mm neck.

Event 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.

• Brand Name: MCS GXL LINER 5/15 DEG 5052X28
• Type of Device: 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: kate jacobson ; 3523771140
• MDR Report Key: 15503212
• MDR Text Key: 300777252
• Report Number: 1038671-2022-01186
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862013507
• UDI-Public: 10885862013507
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/28/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1728-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female