MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NE; HIP COMPONENT

Model Number	PRTLS027
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient dislocated the day after surgery.The surgeon felt that the reason for the dislocation was a ''lack of tension'' , or offset.This was resolved with a bigger stem, creating more offset, and using the varus option, plus a longer head.The surgeon puts this down to surgeon error.Also, the digital templating system was not available before the operation with further complicated matters.Additional information received on 11/16/2020: adding components not revised, patient information and incident code: components not revised: procotyl l beaded and ha coated cup size 54mm / product id: pha06264 / lot no: 1802480.Rim-lock biolox delta ceramic liner 36mm id group e / product id: pha04510 / lot no: 1819068.

• Brand Name: PROFEMUR TL CLASSIC STEM SIZE 7 STRAIGHT SHORT NE
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10911433
• Report Number: 3010536692-2020-00711
• Device Sequence Number: 2715786
• Product Code: JDI
• UDI-Device Identifier: M684PRTLS0271
• UDI-Public: M684PRTLS0271
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K123688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2020

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: PRTLS027
• Device Catalogue Number: PRTLS027
• Device Lot Number: 1845440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention