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

Model Number	26000004
Medical Device Problem Codes	Break (1069); Noise, Audible (3273)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11186341
• Report Number: 3010536692-2021-00017
• Device Sequence Number: 703640
• Product Code: MRA
• UDI-Device Identifier: M684260000041
• UDI-Public: M684260000041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 26000004
• Device Catalogue Number: 26000004
• Device Lot Number: 1513628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2020
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR