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

Model Number	DLXPGE38
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient was revised for liner dissociation.Time to revision was 160 months.Components not revised: bch(r) total femoral head product id : 38ch3800 lot id: not indicated.Profemur(r) cocr neck product id : phac12xx lot id: not indicated.Additional information indication for surgery was osteoarthritis.Bmi: 23.

• Brand Name: DYNASTY A-CLASS 38MM STD GROUP E CROSSLINKED POL
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10307223
• Report Number: 3010536692-2020-00491
• Device Sequence Number: 3417110
• Product Code: LZO
• UDI-Device Identifier: M684DLXPGE381
• UDI-Public: M684DLXPGE381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: Other
• Device Model Number: DLXPGE38
• Device Catalogue Number: DLXPGE38
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR