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

Model Number	38031048
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient underwent left hip resurfacing arthroplasty in 2017.Then was revised due to pain, adverse tissue reaction and elevated ion levels.Additional information received from distributor on 05/05/2021: product id and lot information.

• 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: 11815455
• Report Number: 3010536692-2021-00294
• Device Sequence Number: 14265126
• Product Code: KXA
• UDI-Device Identifier: M684380310481
• UDI-Public: M684380310481
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 1682742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR