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

Catalog Number 38XX-XXXX

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient revised due to loose cup.Revised to a stryker cup, left the stem and put in a 36mm cocr head.

• Brand Name: 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: 6584308
• MDR Text Key: 75761464
• Report Number: 3010536692-2017-00717
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/19/2017

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: Physician
• Device Catalogue Number: 38XX-XXXX
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2017
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 05/23/2017
• 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: 75 YR