MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 48MM LONG NECK; HIP COMPONENT

Model Number	38014835
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient suffered pain, body impairment, debilitating lack of mobility and high levels of toxic metals.Left side.

• Brand Name: CONSERVE® BFH® HEAD 48MM LONG NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9872069
• Report Number: 3010536692-2020-00270
• Device Sequence Number: 19593460
• Product Code: KWA
• UDI-Device Identifier: M684380148351
• UDI-Public: M684380148351
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 38014835
• Device Catalogue Number: 38014835
• Device Lot Number: 055225779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention