MAUDE Adverse Event Report: STRKYER STRYKER TRIDENT PLS SHELL

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

I had original hip replacement surgery (b)(6) acetabular, stryker trident pls shell with stryker secure fit femoral stem both of which failed three months apart.Second surgery (b)(6) after the original surgery refused to correct.The second surgery was the cup.A few months later the stem failed requiring me to undergo a third surgery.I am still recovering in a lot of pain.I am a young female (b)(6).Very limited activity.The cup fell three inches, the stem loosened cause the leg to shorten by 1.5 inches.

• Brand Name: STRYKER TRIDENT PLS SHELL
• Type of Device: SHELL
• Manufacturer (Section D): STRKYER
• MDR Report Key: 4138492
• MDR Text Key: 4931009
• Report Number: MW5038435
• Device Sequence Number: 2
• Product Code: MEH
• 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: 09/22/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 41 YR
• Patient Weight: 54