MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 40MM 15DG GROUP F CROSSLINKED PO; HIP COMPONENT

Model Number DLXPLF40

Device Problem Corroded (1131)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Allegedly, the patient on (b)(6) 2020 had a left revision surgery due to corrosion, on (b)(6) 2020 the patient was revised again due to infection on the side left.

Manufacturer Narrative

Section b.5: additional information in description.

Event Description

Allegedly, the patient on (b)(6) 2020 had a left revision surgery due to corrosion, on (b)(6) 2020 the patient was revised again due to infection on the side left.Additional information received on 29/07/2022: we found 7 additional devices involved on the complaint found in the invoice.

• Brand Name: DYNASTY® A-CLASS® 40MM 15DG GROUP F 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: 15259713
• MDR Text Key: 298236173
• Report Number: 3010536692-2022-00291
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684DLXPLF401
• UDI-Public: M684DLXPLF401
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLXPLF40
• Device Catalogue Number: DLXPLF40
• Device Lot Number: 1613184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2022
• Date Manufacturer Received: 07/29/2022
• 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