MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Model Number	PHA06214
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to septic loosening.
Additional Manufacturer Narrative
Correct awareness date (b)(6) 2019.

• Brand Name: ACETABULAR CUP
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9717859
• Report Number: 3010536692-2020-00125
• Device Sequence Number: 16234837
• Product Code: HWT
• UDI-Device Identifier: M684PHA062141
• UDI-Public: M684PHA062141
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: PHA06214
• Device Catalogue Number: PHA06214
• Device Lot Number: X01383963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR