MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. STEM+(2)PINS. (RX)DR.MONSON

Model Number CPEF0072

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, patient underwent a revision surgery due to the repiphysis stem fracturing at the taper that connected to the custom adapter. The repiphysis stem and custom adapter were removed and a longer midsection and segmental stem were placed.

• Brand Name: STEM+(2)PINS. (RX)DR.MONSON
• Type of Device: STEM
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9859486
• MDR Text Key: 184251743
• Report Number: 3010536692-2019-01124
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CPEF0072
• Device Catalogue Number: CPEF0072
• Device Lot Number: 1123214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2019
• Event Location: No Information
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/20/2020 Patient Sequence Number: 1