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

Model Number 38AM-5235

Device Problem Material Disintegration (1177)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications: evidence of metallosis from imaging and lab results.Note: during the procedure, dr.(b)(6) noted, "upon capsulotomy, large sterile effusion was encountered.I exposed the joint, significant corrosive type tissue was noted and complete debridement was performed.Attempted to disengage the modular neck from the stem, but was unable to remove the short neck.Left in place.There was no significant corrosion or damage to the morse taper.I removed further hypertrophic tissue and necrotic tissue on the femoral side.At that time dr.(b)(6) exchanged the head and added a poly insert to avoid a metal-on-metal articulation.

• 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: 8425962
• MDR Text Key: 138969430
• Report Number: 3010536692-2019-00548
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM-5235
• Device Catalogue Number: 38AM-5235
• Device Lot Number: 076360860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Date Manufacturer Received: 03/08/2019
• 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