MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 32MM STD GROUP C CROSSLINKED POL; HIP COMPONENT

Model Number	DLXPGC32
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported under 3010536692-2016-00812, 3010536692-2016-00813 and 3010536692-2016-00767.This is an additional component associated to the event.
Event or Problem Description
Allegedly the patient was revised due to multiple hip dislocations, having a failed acetabular.(right) additional information received on 12-sep-2019: sae# (b)(6).Allegedly, periprosthetic fracture of the acetabular component patient was seen in clinic post sx between jul 2012-jan 2013.Improvements were slow and the patient was not fully weight beaning.Patient was found to have a failed acetabular on (b)(6) 2013, and the patient underwent a revision with cage reconstruction.

• Brand Name: DYNASTY® A-CLASS® 32MM STD GROUP C CROSSLINKED POL
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10119075
• Report Number: 3010536692-2020-00386
• Device Sequence Number: 14331127
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGC321
• UDI-Public: M684DLXPGC321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DLXPGC32
• Device Catalogue Number: DLXPGC32
• Device Lot Number: 0711382297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 06/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65