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

Catalog Number 110-01-03

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

Revision of left hip components due to aseptic loosening.This event report was received through clinical data collection activites.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific info was not provided, precluding a review of the device history record.

• Brand Name: ACUMATCH L-SERIES FEMORAL STEM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4365524
• MDR Text Key: 5112412
• Report Number: 1038671-2014-00687
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2014

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: 110-01-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/19/2014
• 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