MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS SPIKED CUP; HIP COMPONENT

Catalog Number 38SP-4046

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104); Chemical Exposure (2570); Test Result (2695)

Event Date 11/20/2013

Event Type  Injury  

Event Description

Allegedly, patient was revised due to mom complications (pain and metallosis; corrosion and soft tissue damage; dislocation; pseudotumors): left.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01207, -01208, -01209.

• Brand Name: CONSERVE(R) PLUS SPIKED 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 ; 901867-477
• MDR Report Key: 4803597
• MDR Text Key: 5895486
• Report Number: 3010536692-2015-01206
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38SP-4046
• Device Lot Number: 088571499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/20/2013
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2015
• 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
• Patient Age: 70 YR