MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH FEMORAL HEAD, BIOLOX DELTA

Catalog Number 170-36-07

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to infection.

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Engineering evaluation noted that the revision reported was likely the result of the patient's fall, which fractured the greater trochanter, leading to an additional surgery and an infection.

Event Description

Index surgery: (b)(6) 2017.Revision due to infection.

• Brand Name: EXACTECH FEMORAL HEAD, BIOLOX DELTA
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 6664936
• MDR Text Key: 78313919
• Report Number: 1038671-2017-00414
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• 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: 08/08/2018

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 Catalogue Number: 170-36-07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 06/19/2017
• Supplement Dates FDA Received: 08/08/2018
• 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
• Patient Weight: 136