MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY BF SHELL 54MM GROUP E; HIP COMPONENT

Model Number	DSBFGE54
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2015
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
(b)(4).Allegedly, patient was revised due to pain and loosening.Trochanteric non-union due to inadequate reattachment and or early weight bearing.He has had lack of ingrowth of the acetabular component.Operative side: right.The dynasty biofam shell, dynasty a-class polyliner, and screws were revised.Components not revised: product name: profemur® neck a/r 8dg short cobalt chrome catalog number: phac1232 lot number: 1407107.Product name: profemur® gladiator® cemented stem sz 4 catalog number: rglcm04 lot number: 1453286.Product name: conserve® a-class® bfh® head short neck 36mm catalog number: 38am3604 lot number: 1452346.

• Brand Name: DYNASTY BF SHELL 54MM GROUP E
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12381671
• Report Number: 3010536692-2021-00450
• Device Sequence Number: 14469837
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGE541
• UDI-Public: M684DSBFGE541
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: DSBFGE54
• Device Catalogue Number: DSBFGE54
• Device Lot Number: 1426885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 10/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR