MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TL STEM SZ 5; HIP COMPONENT

Model Number	PRTL0025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2015
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, subject was seen in emergency room with right hip pain for 2 weeks, crunching with motion and difficulty ambulating.Liner fracture was confirmed by x ray and ct of the hip.Subject had a revision and removal of the original acetabular, liner, modular neck and femoral head and was discharged on (b)(6) 2015.
Additional Manufacturer Narrative
After the investigation it was found that there is no alleged deficiency against the device.Therefore the event is not reportable.Please void the initial report.

• Brand Name: PROFEMUR TL STEM SZ 5
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9813778
• Report Number: 3010536692-2020-00206
• Device Sequence Number: 11457557
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00251
• UDI-Public: M684PRTL00251
• 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: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: PRTL0025
• Device Catalogue Number: PRTL0025
• Device Lot Number: 1447907
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 09/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 94