MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS HEAD; HIP COMPONENT

Model Number 38AM5635

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

This event was initially reported under 3010536692-2019-01083.This is an additional component associated to the event according the new information provided.

Event Description

Allegedly, patient was revised for a broken neck.Additional information received on 02/05/2021: allegedly, on the revision surgery dr.(b)(6) also found a pseudo-tumor.

• Brand Name: CONSERVE TOTAL A-CLASS HEAD
• 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: 11342086
• MDR Text Key: 232327108
• Report Number: 3010536692-2021-00083
• Device Sequence Number: 1
• Product Code: JDL
• 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: Physician
• Type of Report: Initial
• Report Date: 02/18/2021

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: 38AM5635
• Device Catalogue Number: 38AM5635
• Device Lot Number: 046334711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/18/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 91