MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 56MM GROUP F; HIP COMPONENT

Model Number	DSPCGF56
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Unequal Limb Length (4534)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent left thr on (b)(6) 2017 with a superpath technique.Patient complaining about groin pain and suing primary surgeon.Primary surgeon would not carry out a revision as all components are well fixed and aligned.Patient seeking revision with another surgeon.Additional information received on 03/22/2021 from distributor surgical specialties: adding incident description, date of revision 19 mar 2021, confirming head and stem were not revised and cup, liner and screws were revised with other manufacturer's components.Allegedly, revising surgeon reported cup malposition with leg length discrepancy and impingement.Components not revised: biolox delta femoral head / product id: pha04408 / lot no.: 1703553.Profemur l classic femoral stem / product id: phas5506 / lot no.: 1697533.(b)(6)- c1082.

• Brand Name: DYNASTY PC SHELL 56MM GROUP F
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11668692
• Report Number: 3010536692-2021-00194
• Device Sequence Number: 14203074
• Product Code: LZO
• UDI-Device Identifier: M684DSPCGF561
• UDI-Public: M684DSPCGF561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: Health Professional
• Device Model Number: DSPCGF56
• Device Catalogue Number: DSPCGF56
• Device Lot Number: 1700897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR