MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR(R) BIPOLAR; HIP COMPONENT

Catalog Number GLBP-3656

Device Problem Material Separation (1562)

Patient Problem Fall (1848)

Event Date 11/29/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the pt.Fell and consequently the bipolar shell disassociated.Surgeon revised the shell with concern that the locking detail may have been damaged from the fall.

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.

• Brand Name: GLADIATOR(R) BIPOLAR
• Type of Device: HIP COMPONENT
• 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: 4330874
• MDR Text Key: 18817302
• Report Number: 3010536692-2014-01807
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

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?: Yes
• Device Operator: Other
• Device Catalogue Number: GLBP-3656
• Device Lot Number: 1524013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention