MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS / STRYKER CORP. TRIDENT POLY HEAD HIP REPLACEMENT; STRYKER TOTAL HIP

Model Number POLY HEAD IS 7007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Swelling (2356)

Event Date 08/23/2018

Event Type  Injury  

Event Description

Reported that pt had left recurrent effusion.

• Brand Name: TRIDENT POLY HEAD HIP REPLACEMENT
• Type of Device: STRYKER TOTAL HIP
• Manufacturer (Section D): STRYKER ORTHOPAEDICS / STRYKER CORP.
• MDR Report Key: 7938765
• MDR Text Key: 123238466
• Report Number: MW5080389
• Device Sequence Number: 2
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/03/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: POLY HEAD IS 7007
• Device Catalogue Number: 7007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 69