MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. STEM EXTRACTOR LOOP; HIP INSTRUMENT

Catalog Number 4700-EL00

Device Problems Disconnection (1171); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Allegedly the extractor kept disengaging during repeated attempts to remove the stem; threads were deformed.The surgery time was extended greater than 30 minutes.

Manufacturer Narrative

This is the same event as 3010536692-2015-00629.Report will be updated when investigation is complete.Trends will be evaluated.

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

• Brand Name: STEM EXTRACTOR LOOP
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 901867-441
• MDR Report Key: 4664407
• MDR Text Key: 19725082
• Report Number: 3010536692-2015-00630
• Device Sequence Number: 1
• Product Code: HWB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4700-EL00
• Device Lot Number: A078092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/02/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 04/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR