MAUDE Adverse Event Report: EXACTECH, INC. CONNEXION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/07/2023

Event Type  Injury  

Event Description

As reported via legal documentation, a patient had primary left hip replacement surgery on (b)(6) 2015.They underwent left hip revision surgery on (b)(6) 2023, approximately 7 years 10 months after their initial implantation.The patient claims to have suffered severe pain and a revision surgery as a result of this exactech device.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

Pending investigation.

Manufacturer Narrative

H10.Updated/additional information - g1.G4.H6.The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.

• Brand Name: CONNEXION GXL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523782617
• MDR Report Key: 17370974
• MDR Text Key: 319492693
• Report Number: 1038671-2023-01740
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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