MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® FEMORAL RESURFACING HEAD 50MM; HIP COMPONENT

Model Number 38031050

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to adverse tissue reaction to particle debris revision (b)(6); side: r; primary asa: p2-mild disease not incapacitating.The following component has no alleged deficiency and was not revised during this surgery: conserve® thin shell ha coated 50mm id 56mm od beaded 38ha5056 lot # 027388279 qty.1.

• Brand Name: CONSERVE® FEMORAL RESURFACING HEAD 50MM
• 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: 8815625
• MDR Text Key: 151847245
• Report Number: 3010536692-2019-00911
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M684380310501
• UDI-Public: M684380310501
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K944752
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38031050
• Device Catalogue Number: 38031050
• Device Lot Number: 037419243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2019
• Date Manufacturer Received: 07/15/2019
• 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: 47 YR