MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PRIME A-CLASS LINER 0°LIP 36MM; HIP COMPONENT

Model Number P2LXSC36

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the liner locked diagonally for the first time on (b)(6) operation after converting from a6 tab to a12 tab.Tried to remove the polyliner with a drill and tap in the instrument set, but no poly came out.Update please disregard 6-tab liner at this moment.So that's why reason is that there is only the 12-tab liner included on the incident form.

Manufacturer Narrative

Please void all reports for medwatch no.: 3010536692-2020-00326.No serious injury has occurred as a result of this incident.This is a non-reportable incident, and this event should not have been reported.This report should be voided.

• Brand Name: PRIME A-CLASS LINER 0°LIP 36MM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9933324
• MDR Text Key: 186710845
• Report Number: 3010536692-2020-00326
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P2LXSC36
• Device Catalogue Number: P2LXSC361816848
• Device Lot Number: 1816848
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2020
• Date Manufacturer Received: 03/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention