MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) SF W/HM TECH. FEMORAL; HIP COMPONENT

Model Number 38HM-1046

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient revised due to mom complications.

Manufacturer Narrative

Updated part and lot number.

• Brand Name: CONSERVE(R) SF W/HM TECH. FEMORAL
• 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: 7553436
• MDR Text Key: 109533502
• Report Number: 3010536692-2018-00735
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 38HM-1046
• Device Catalogue Number: 38HM-1046
• Device Lot Number: 11637963110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2018
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 03/05/2019
• 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