MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL E SHELL SCREW; HIP COMPONENT

Model Number PHA02930

Device Problems Unstable (1667); Failure to Osseointegrate (1863)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Investigation completed.Evaluation codes added.

Event Description

Allegedly, the patient's acetabular components were revised on (b)(6) 2008 due to rotational instability, and a hematoma was found and removed during the operation.This patient was later revised on (b)(6) 2017 due to a fractured modular neck (incident group (b)(4)).

• Brand Name: PROCOTYL E SHELL SCREW
• 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: 10503124
• MDR Text Key: 205952748
• Report Number: 3010536692-2020-00606
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA02930
• Device Catalogue Number: PHA02930
• Device Lot Number: U0686785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2020
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention