MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER SHORT HIP COMPONENT

Model Number 26000017

Device Problem Material Disintegration (1177)

Patient Problem Reaction (2414)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly , the suspicion of adverse reaction to metal debris may be especially between neck and head. Dr. Wants to investigate the existence of adverse reaction to metal debris as following. Used our profemurxm, changeable neck, metal head only and used depuy pina cup and marason liner 28mm diameter flat. A few days ago, the patient complained of abnormal noise from his joint spinning prevention tab of 6 pin cup marathon liner 4 out of 6 damaged. Replace with marathon liner 32mm flat. Our steam is also replaced with a changeable neck ar8 long and a delta head 32 mm long. (b)(6).

• Brand Name: COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER SHORT
• 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: 10361494
• MDR Text Key: 201524894
• Report Number: 3010536692-2020-00546
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K004043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000017
• Device Catalogue Number: 26000017
• Device Lot Number: 1485543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2020
• Event Location: No Information
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/04/2020 Patient Sequence Number: 1