MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

Model Number PHA04416

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This event was reported under 3010536692-2019-01052 and 3010536692-2019-01051.This is an additional component associated to the event.

Event Description

Allegedly the surgeon reported that the insert was loose and rolled inside the shell.The cup, insert, head and neck were revised.Head was articulating directly on the shell.Pre-op x-ray and components included.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• 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: 10115329
• MDR Text Key: 193687461
• Report Number: 3010536692-2020-00385
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 1551099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2019
• Date Manufacturer Received: 08/28/2019
• 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: 48 YR