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

Model Number	38AM5235
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient suffered mom complications.
Additional Manufacturer Narrative
Update patient information.

• Brand Name: CONSERVE TOTAL A-CLASS HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9954049
• Report Number: 3010536692-2020-00336
• Device Sequence Number: 2900676
• Product Code: JDL
• UDI-Device Identifier: M68438AM52351
• UDI-Public: M68438AM52351
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: Other
• Device Model Number: 38AM5235
• Device Catalogue Number: 38AM5235
• Device Lot Number: 067447837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention