MAUDE Adverse Event Report: STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO. LTD. HIP REPLACEMENT; PROSTHESIS, HIP SEMI-CONSTRINED, METAL/POLYMER, CEMENTED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Swelling (2091); Loss of Vision (2139); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)

Event Date 01/17/2019

Event Type  Injury  

Event Description

A hip fracture was misdiagnosed and i had a hip replacement surgery for a hip fracture after the surgery.I was disfigured and still unable to walk two months later.My leg , foot and ankles are swollen.I experienced vision loss, hip and leg pain, and unable to walk.

• Brand Name: HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP SEMI-CONSTRINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO. LTD.
• MDR Report Key: 8336217
• MDR Text Key: 136457142
• Report Number: MW5083967
• Device Sequence Number: 1
• 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: 02/10/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 75 YR