MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH M-SERIES STRAIGHT FEMORAL STEM

Catalog Number 150-07-16

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2001.Revision of left hip components - reason unknown.

• Brand Name: ACUMATCH M-SERIES STRAIGHT FEMORAL STEM
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 6724288
• MDR Text Key: 80399495
• Report Number: 1038671-2017-00476
• Device Sequence Number: 1
• Product Code: JDI
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150-07-16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• 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 Age: 40 YR
• Patient Weight: 46