MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL; SEE H10

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported via a legal notification that a patient, had a hip arthroplasty on (b)(6) 2014 then the patient underwent revision surgery on (b)(6) 2022, approximately 8 years, 5 months post implant.The legal documentation provided is not specific to the limb affected by the device types.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.H6.Investigation results - there is no specific acumatch gxl device information provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: ACUMATCH GXL
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17215548
• MDR Text Key: 317988396
• Report Number: 1038671-2023-01480
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention