MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

Model Number	26000010
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, right leg is short, cup is too vertical, patient has dislocated 3 times and there is lucency around the cup to indicated that it has poor in growth.Cup, screws /liner/head/neck were pulled.Stryker cup went in with our head and neck.

• Brand Name: CERAMIC FEMORAL HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10341161
• Report Number: 3010536692-2020-00530
• Device Sequence Number: 16910549
• Product Code: MRA
• UDI-Device Identifier: M684260000101
• UDI-Public: M684260000101
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: 26000010
• Device Catalogue Number: 26000010
• Device Lot Number: 1555037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR