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

Model Number 26000004

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

(b)(4).Previously reported pain in r hip investigated via mri, found to have two lesions at the r hip joint.Findings most consistent with particle disease as a result of primary hip implant.Participant was revised in or on (b)(6) 2018 (or report lists pseudotumor and corrosion as diagnosis) all components of implant were removed.Participant was discharged on (b)(6) 2018.(b)(4).Pain.

Event Description

(b)(4).Previously reported pain in r hip investigated via mri, found to have two lesions at the r hip joint.

• Brand Name: CERAMIC FEMORAL HEAD
• 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: 9142775
• MDR Text Key: 162476379
• Report Number: 3010536692-2019-01067
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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
• Device Operator: Other
• Device Model Number: 26000004
• Device Catalogue Number: 26000004
• Device Lot Number: 0401114383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 01/23/2020
• 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
• Patient Age: 40 YR
• Patient Weight: 47