MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE CUP 50MM ID 60MM OD; HIP COMPONENT

Model Number 38XXXX60

Device Problem Material Disintegration (1177)

Patient Problems Hearing Loss (1882); Neuropathy (1983)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient received a left total hip arthroplasty and was suffering ringing in ears, hearing loss, numbness in all fingers of the left hand, fine tremor of the right hand and has developed elevated cobalt levels.

Manufacturer Narrative

See attached.- attachment: [wd011615.Pdf].

• Brand Name: CONSERVE CUP 50MM ID 60MM OD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9777144
• MDR Text Key: 181776141
• Report Number: 3010536692-2020-00174
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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
• Device Operator: Other
• Device Model Number: 38XXXX60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2020
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 05/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention