MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® FEMORAL RESURFACING HEAD 46MM; HIP COMPONENT

Model Number	38031046
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, patient was revised due to pain; periprosthetic fracture stem; adverse soft tissue reaction to particle debris.Revision (b)(4).Side:r: primary asa: p2 - mild disease not incapacitating.Components not revised: conserve® thin shell ha coated 46mm id 52mm od beaded (b)(4).

• Brand Name: CONSERVE® FEMORAL RESURFACING HEAD 46MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8996413
• Report Number: 3010536692-2019-01033
• Device Sequence Number: 16975125
• Product Code: KXA
• UDI-Device Identifier: M684380310461
• UDI-Public: M684380310461
• Combination Product (Y/N): N
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 38031046
• Device Catalogue Number: 38031046
• Device Lot Number: 86366885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR