MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL NECK SLEEVE; HIP COMPONENT

Model Number 38NS0035

Device Problem Mechanical Problem (1384)

Patient Problem Skin Discoloration (2074)

Event Type  Injury  

Manufacturer Narrative

Event was reported under number 3010536692-2020-00693 & 3010536692-2020-00795.This is an additional component associated to the event.

Event Description

Allegedly, the neck sleeve and head came out as one during revision surgery and neck trunnion was black.Left hip head and necks were replaced components not revised: conserve® plus cup product number 38024450 lot number 029783710.Profemur® plasma z stem product number pha00262 lot number 049943762.

• Brand Name: CONSERVE TOTAL NECK SLEEVE
• 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: 11095421
• MDR Text Key: 224393079
• Report Number: 3010536692-2020-00796
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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: Health Professional
• Device Model Number: 38NS0035
• Device Catalogue Number: 38NS0035
• Device Lot Number: 02847175510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2020
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 12/30/2020
• 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