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

Model Number 38AM-4604

Device Problem Material Disintegration (1177)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications: pain in the left hip, progressed to become incapacitating despite conservative treatment.Apparently, recent blood levels of cobalt and chromium were elevated.(left).

• Brand Name: CONSERVE® A-CLASS® BFH® 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: 8588118
• MDR Text Key: 144322393
• Report Number: 3010536692-2019-00734
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM-4604
• Device Catalogue Number: 38AM-4604
• Device Lot Number: 115284399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2019
• Date Manufacturer Received: 05/06/2019
• 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
• Patient Age: 43 YR