MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 42MM FEMORAL HEAD; HIP COMPONENT

Model Number	38AC4200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to head dislocated.Additional information received on 10/08/2020 from (b)(6): adding product information.Second revision captured under incident number: (b)(4).

• Brand Name: CONSERVE TOTAL A-CLASS 42MM FEMORAL HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10766610
• Report Number: 3010536692-2020-00675
• Device Sequence Number: 3864968
• Product Code: JDL
• UDI-Device Identifier: M68438AC42001
• UDI-Public: M68438AC42001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 38AC4200
• Device Catalogue Number: 38AC4200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR