MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 36MM; HIP COMPONENT

Model Number	PHA04436
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when the investigation is complete.
Event or Problem Description
Allegedly, the patient was revised due to dislocation.The doctor pulled the neck, head, sleeve, liner, and 3 screws and cemented in a biomet constrained liner.The patient had a previous revision for mom, incident group 19060012, a second revision for infection, incident group 19060187, and a third revision for dislocation, incident group 19060015 items not revised: dynasty biofoam shell dsbfgg60 lot 079859623, profemur plasma z stem pha00270 lot 067445032.
Additional Manufacturer Narrative
Updated initial reporter information.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 36MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9358640
• Report Number: 3010536692-2019-01150
• Device Sequence Number: 469790
• Product Code: LZO
• UDI-Device Identifier: M684PHA044361
• UDI-Public: M684PHA044361
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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
• Operator of Device: Other
• Device Model Number: PHA04436
• Device Catalogue Number: PHA04436
• Device Lot Number: 1807262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR