MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS STEM INSERTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-1500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2019

Event Type  malfunction  

Event Description

An elderly female had a bipolar hemiarthroplasty.Post-operative x-ray revealed a metallic foreign body near the left hip prosthesis.The patient returned to the operation room the next day for exploration and removal of the foreign body.The foreign body was determined to be a piece of metal from the femoral impactor.

• Brand Name: STEM INSERTER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 8463556
• MDR Text Key: 140296165
• Report Number: 8463556
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-1500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2019
• Type of Device Usage: N
• Patient Sequence Number: 1