MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL A-CLASS HEAD

Model Number 38AM4600

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 09/29/2009

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly patient was squeaking and the doctor feels this is not a product issue but is due to excessive rom of the patient.Additional information received from legal, 09/23/2019.Patient was revised due to dislocation.

• Brand Name: CONSERVE(R) TOTAL A-CLASS HEAD
• Type of Device: HEAD
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9226871
• MDR Text Key: 163716175
• Report Number: 3010536692-2019-01118
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K162026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38AM4600
• Device Catalogue Number: 38AM4600
• Device Lot Number: 087466395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2009
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2019
• Date Manufacturer Received: 09/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR