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

Model Number 3812-4450

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications: pain; metallosis; popping sensation and limited mobility.(right).

Manufacturer Narrative

After a recently review, it was determined that a supplemental report stating, that this event was incorrectly reported was submitted.This supplemental report (3010536692-2017-01219-01) was submitted in error.We apologize for any inconvenience that this may have caused.The initial report that was submitted on 09/12/2017 is correct.

Manufacturer Narrative

After the initial report, it was determined that there was no complaint alleged against the device.Please void the initial report.

• Brand Name: CONSERVE® 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: 6860158
• MDR Text Key: 85901232
• Report Number: 3010536692-2017-01219
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2017

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: Other
• Device Model Number: 3812-4450
• Device Catalogue Number: 3812-4450
• Device Lot Number: 089860405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2017
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 08/23/2017; 08/23/2017
• Supplement Dates FDA Received: 01/22/2019; 01/25/2019
• 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