MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR RENAISSANCE CLASSIC RDC FLARE SZ 14 V8D; HIP COMPONENT

Model Number	PLLER014
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
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 is stating she might be having metal reaction in hip replacement.

• Brand Name: PROFEMUR RENAISSANCE CLASSIC RDC FLARE SZ 14 V8D
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9722489
• Report Number: 3010536692-2020-00135
• Device Sequence Number: 366844
• Product Code: JDI
• UDI-Device Identifier: M684PLLER0141
• UDI-Public: M684PLLER0141
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: PLLER014
• Device Catalogue Number: PLLER014
• Device Lot Number: 1615079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention