MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 48MM; HIP COMPONENT

Model Number	38031048
Medical Device Problem Codes	Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Codes	Pain (1994); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See investigation attached.
Event or Problem Description
Allegedly, revision surgery required.Patient presented pseudotumor, elevated metal ion blood levels, and pain.Device failure attributed to adverse tissue reaction to metal debris, corrosion and resultant metal ions.Left side.

• Brand Name: CONSERVE FEMORAL RESURFACING HEAD 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10667073
• Report Number: 3010536692-2020-00654
• Device Sequence Number: 4283902
• Product Code: KXA
• UDI-Device Identifier: M684380310481
• UDI-Public: M684380310481
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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: 38031048
• Device Catalogue Number: 38031048
• Device Lot Number: 1001206131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention