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

Model Number 26000011

Device Problems Unstable (1667); Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the patient has pain and loosening.

Manufacturer Narrative

Section h.6: medical device problem added (1667) and the type of investigation has been update.

Event Description

Allegedly, the patient has pain and loosening.Additional information received on april 6, 2022: allegedly, patient had pain and recurrent instability.The cup, screws, liner, head and neck were revised.The stem pha00606, stem revision "profemur® z", lot: 068501170 was not revised.Additional information received on may 3, 2022: during revision surgery, patient received implanted a phac1252 profemur® neck var/val 8dg short cobalt chrome and a 26000020 cocr transcend® femoral head 28mm slt taper x-long from wright medical.Patient received also a liner, insert and acetabular shell from stryker medical.Patient has been complaining of unknown issues since her revision on (b)(6) 2017.This complaint has been captured under microport reference group number: (b)(4).

• 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: 13061353
• MDR Text Key: 282628390
• Report Number: 3010536692-2021-00599
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000111
• UDI-Public: M684260000111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000011
• Device Catalogue Number: 26000011
• Device Lot Number: 1496082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2021
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female