MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE HM FEMORAL COMPONENT CEMENTED 52MM; HIP COMPONENT

Model Number	38HM1052
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient has been experiencing pain in his left hip and high levels of chromium and cobalt were confirmed by a blood test.Additional information received on 07/30/2020: adding scheduled revision surgery date and patient name.

• Brand Name: CONSERVE HM FEMORAL COMPONENT CEMENTED 52MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10428832
• Report Number: 3010536692-2020-00584
• Device Sequence Number: 16742113
• Product Code: LZO
• UDI-Device Identifier: M68438HM10521
• UDI-Public: M68438HM10521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 38HM1052
• Device Catalogue Number: 38HM1052
• Device Lot Number: 11638949010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention