MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL 40MM BCH FEMORAL HEAD; HIP COMPONENT

Model Number 38CH4000

Device Problems Material Disintegration (1177); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, 3 years post operatively the patient felt squeaking and limited range of motion.Liner was not in dynasty cup.It was disassembled and they sucked out about 180cc of black oil out of the capsule.Product not revised: cup.

• Brand Name: CONSERVE TOTAL 40MM BCH 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: 9598038
• MDR Text Key: 175392848
• Report Number: 3010536692-2020-00054
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M68438CH40001
• UDI-Public: M68438CH40001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38CH4000
• Device Catalogue Number: 38CH4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2019
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention