MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOWN WHITESIDE HIP SYSTEM; HIP COMPONENT

Model Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, the patient was revised due to unknown reasons.Updates on 15 december 2020: a revision was stated to be scheduled for this patient.Provided x-rays reveal a dislocation of the tha.

• Brand Name: UNKNOWN WHITESIDE HIP SYSTEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 11011679
• MDR Text Key: 221525429
• Report Number: 3010536692-2020-00766
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization