MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TL STEM SZ 6; HIP COMPONENT

Model Number	PRTL0026
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to periprosthetic fracture stem.Revision njr number: (b)(4) side:r.Primary asa: p2 - mild disease not incapacitating.Components not revised: procotyl l beaded and ha coated cup size 58mm product id pha06268 lot id 111.Rim-lock biolox delta ceramic liner 36mm id group f product id pha04512 lot id 111.

• Brand Name: PROFEMUR TL STEM SZ 6
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10337533
• Report Number: 3010536692-2020-00502
• Device Sequence Number: 19627704
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00261
• UDI-Public: M684PRTL00261
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K060358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: Health Professional
• Device Model Number: PRTL0026
• Device Catalogue Number: PRTL0026
• Device Lot Number: 111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention