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

Model Number DLXPLE38

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

Allegedly, revision due to liner disassociation, wear, and possible impingement.Products not revised: prglcle4 profemur® gladiator® classic plasma size 4 varus 8 dg neck, lot: 1787126, qty: 1 dsbfge54 dynasty® bf shell 54mm group e, lot: 1787915, qty: 1.

Manufacturer Narrative

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

• 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 Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18303104
• MDR Text Key: 330185349
• Report Number: 3010536692-2023-00222
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male