MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 42MM; HIP COMPONENT

Model Number 38AC-4200

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 01/01/2012

Event Type  Injury  

Event Description

Allegedly the patient began having some pain in left hip in 2012.Work up was negative.Symptoms progressed and became much worst in 2018.Work up last shown no evidence of loosening, osteolysis, infection or subsidence.However, co and cr ions are extremely high.We are planning an exploratory autotomy to conclusive rule out loosening of acetabular and/or metallosis.Additional information received from clinical on (b)(6) 2019: patient had exploratory surgery on (b)(6) 2019 resulting in explant of study devices.

• Brand Name: CONSERVE® TOTAL A-CLASS® 42MM
• 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: 8343754
• MDR Text Key: 136272927
• Report Number: 3010536692-2019-00379
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AC-4200
• Device Catalogue Number: 38AC-4200
• Device Lot Number: 0411347584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Date Manufacturer Received: 01/16/2019
• 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: 58 YR
• Patient Weight: 88