MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Catalog Number PHA0-6216

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly in (b)(6) 2016 the patient referred recurrence pain.In (b)(6) 2017 during revision surgery there were soft tissue damage and cystic mass formation.Adverse local tissue reactions (altr) became apparent.

• Brand Name: ACETABULAR CUP
• 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 ; 9018674771
• MDR Report Key: 6413650
• MDR Text Key: 70243508
• Report Number: 3010536692-2017-00390
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: PHA0-6216
• Device Lot Number: 1428299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/09/2017
• Date Manufacturer Received: 03/09/2017
• 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
• Patient Age: 51 YR
• Patient Weight: 105