MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 10 V8D; HIP COMPONENT

Model Number	PLLER010
Medical Device Problem Code	Break (1069)
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 evaluate.
Event or Problem Description
Allegedly, patient undergoing left hip revision arthroplasty due to fracture of the femoral stem.Implanted products not revised: dynasty® pc shell 50mm group c - product id: dspcgc50, lot number: 1555466.Cancellous 6.5mm self-tapping bone screw 2.0cm length - product id: 18080301, lot number: 1640236.Cancellous 6.5mm self-tapping bone screw 1.5cm length - product id: 18080300, lot number: 1641256.
Additional Manufacturer Narrative
Updated initial reporter information.

• Brand Name: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 10 V8D
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9904117
• Report Number: 3010536692-2020-00296
• Device Sequence Number: 702168
• Product Code: JDI
• UDI-Device Identifier: M684PLLER0101
• UDI-Public: M684PLLER0101
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: PLLER010
• Device Catalogue Number: PLLER010
• Device Lot Number: 1558808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR