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

Model Number PHA06214

Device Problem Loss of Osseointegration (2408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to septic loosening.

Manufacturer Narrative

Correct awareness date (b)(6) 2019.

• Brand Name: ACETABULAR CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9717859
• MDR Text Key: 182361529
• Report Number: 3010536692-2020-00125
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: M684PHA062141
• UDI-Public: M684PHA062141
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR