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

Model Number 26000005

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, the patient presented to hospital complaining right hip pain and squeaking.X ray taken indicated worn of prosthetic ball and socket.Surgeon found darkened tissue consistent with metallosis.Further inspection revealed what appeared to be a complete dissociation of the acetabular liner from the underlying acetabulum.Surgeon also noted: significant wear of the locking mechanism at the 10 o´clock position of the polyethylene was shredded off the edge of the polyethylene.The femoral head, the shell and liner were each removed.The acetabular component and liner were replaced with devices not manufactured by wright medical.

Manufacturer Narrative

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

Manufacturer Narrative

Section h.6: type of investigation has been updated.

• 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: 12914017
• MDR Text Key: 281583430
• Report Number: 3010536692-2021-00575
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000051
• UDI-Public: M684260000051
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

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: 26000005
• Device Catalogue Number: 26000005
• Device Lot Number: 0401114411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/01/2021
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 11/01/2021; 11/01/2021
• Supplement Dates FDA Received: 01/24/2022; 10/20/2023
• 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