MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY A-CLASS 38MM 15DG GROUP E CROSSLINKED PO; HIP COMPONENT

Model Number DLXPLE38

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to dislocated liner.Components not revised: profemur® renaissance® stem reduced sz 14, product id: pls0r414, lot id: 1750310, conserve® total medium neck sleeve, product id: 38ns0000, lot id: 1723377, profemur® neck var/val 8dg short cobalt chrome, product id: phac1252, lot id: 1736349.

• Brand Name: DYNASTY A-CLASS 38MM 15DG GROUP E CROSSLINKED PO
• 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: 10027022
• MDR Text Key: 190502444
• Report Number: 3010536692-2020-00353
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684DLXPLE381
• UDI-Public: M684DLXPLE381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLXPLE38
• Device Catalogue Number: DLXPLE38
• Device Lot Number: 1749003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2020
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention