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

Model Number 26000004

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient visited the hospital on 12/11 because he heard a squeaking noise from his hip joint.The ceramic head was confirmed to be damaged by x-ray photography, so surgery was performed on (b)(6).In surgery.Damaged ceramic head and combined product afj cup (pha03618), delta head m (pha04404), ar15 degree long neck (pha01244) (used with front twist) was replaced.Additional information received on 12/28/2020 from hirohito nakayama: adding neck and insert lot numbers, also confirming revision facility.Japan-oc-000000092.

• 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: 11186341
• MDR Text Key: 227479499
• Report Number: 3010536692-2021-00017
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000041
• UDI-Public: M684260000041
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/22/2021

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: 1513628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2020
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR