MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
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, the femoral neck of the device suddenly failed, breaking into pieces.Additional information: left hip.
Additional Manufacturer Narrative
Additional information was received on 10/29/2020: updated incident description and lot number.
Event or Problem Description
Allegedly, the femoral neck of the device suddenly failed, breaking into pieces.Additional information: left hip additional information provided on 10/29/2020 by (b)(4): product id and lot information.
Additional Manufacturer Narrative
Added lot information that was not included on the previous report.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10043265
• Report Number: 3010536692-2020-00357
• Device Sequence Number: 14069600
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: U1088875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 04/23/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 11/10/2020; 11/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention