MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 56MM; HIP COMPONENT

Model Number 38AC-5600

Device Problem Material Disintegration (1177)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to pain, possibly high cocr levels.The patient is very active and has broken a previous neck in 2012.Dr.(b)(6) have been informed that this neck has been taken off the market.Additionally, they have been urged to remove the current neck for that reason.In surgery the head, neck and sleeve came off as one.The cup was replaced with a stryker cup and a dual mobility, our 28mm head and a long straight neck was used also.

• Brand Name: CONSERVE® TOTAL A-CLASS® 56MM
• 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: 8555278
• MDR Text Key: 143248073
• Report Number: 3010536692-2019-00707
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AC-5600
• Device Catalogue Number: 38AC-5600
• Device Lot Number: 07990119810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2019
• Date Manufacturer Received: 04/18/2019
• 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: 63 YR