MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS CUP

Model Number 3802-4652

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, (b)(6) 2019.Patient was revised due to dislocation.

Manufacturer Narrative

Updated event problem codes.This is an additional component related to the event reported under 3010536692-2019-01118.The products were no accessible for analysis.

• Brand Name: CONSERVE(R) PLUS CUP
• Type of Device: CUP
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9226870
• MDR Text Key: 164110202
• Report Number: 3010536692-2019-01119
• Device Sequence Number: 1
• Product Code: KWA
• 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: 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: 3802-4652
• Device Catalogue Number: 3802-4652
• Device Lot Number: 058540100
• 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