MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. BIPOLAR ACETABULAR SHELL WITH DURAMER LINER; HIP COMPOENET

Catalog Number 3110-2845

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly the surgeon performed bha surgery on (b)(6) 2016.The patient occurred dislocated and the surgeon found it at (b)(6) 2016.So the surgeon performed revision surgery to tha at (b)(6) 2016.During revision surgery, the surgeon found disassociation between cup and head.The surgeon asked us why disassociation occurred.Does this issue relate to manufacturing deficiency for incident #(b)(4)? the parts are not consignment parts.

• Brand Name: BIPOLAR ACETABULAR SHELL WITH DURAMER LINER
• Type of Device: HIP COMPOENET
• 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 ; 9018674771
• MDR Report Key: 6103576
• MDR Text Key: 59966283
• Report Number: 3010536692-2016-01403
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3110-2845
• Device Lot Number: 1654224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/30/2016
• Date Manufacturer Received: 10/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention