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

Model Number 38HM-1046

Device Problems Material Disintegration (1177); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091)

Event Type  Injury  

Event Description

Allegedly, patient suffering with mom complications: pain; popping/grinding, swelling, difficulty ambulating, elevated cocr levels left.Additional information received from litigation on 01/08/2019.Patient now revised.Added the explant date.(left).

• Brand Name: CONSERVE(R) SF W/HM TECH. FEMORAL COMPONENT
• 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: 8290795
• MDR Text Key: 134529366
• Report Number: 3010536692-2019-00154
• 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
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38HM-1046
• Device Catalogue Number: 38HM-1046
• Device Lot Number: 017402322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2018
• Date Manufacturer Received: 01/08/2019
• 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