MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) TL STEM SZ 3; HIP COMPONENT

Model Number	PRTL0023
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Sae-051-202r-1 previously reported pain in r hip investigated via mri, found to have two lesions at the r hip joint.Findings most consistent with particle disease as a result of primary hip implant.Participant was revised in or on (b)(6) 2018 (or report lists pseudotumor and corrosion as diagnosis) all components of implant were removed.Participant was discharged on (b)(6) 2018.Sae-051-202r-2, pain.
Additional Manufacturer Narrative
Corrected device code for this incident report.
Event or Problem Description
(b)(4).Previously reported pain in r hip investigated via mri, found to have two lesions at the r hip joint.(see attachment).

• Brand Name: PROFEMUR(R) TL STEM SZ 3
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9142781
• Report Number: 3010536692-2019-01066
• Device Sequence Number: 19594647
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00231
• UDI-Public: M684PRTL00231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: PRTL0023
• Device Catalogue Number: PRTL0023
• Device Lot Number: 0301068670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 47