MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. FEMORAL STEM 36 NECK 20X15X165; HIP PROSTHESIS

Model Number 523794

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/01/2015

Event Type  Injury  

Event Description

The reporter states that about 3.5 years after the implantation of his left hip system, he began having the same symptoms from prior to the surgery.The pt reported symptoms of extreme pain as well as ambulation difficulties describing himself as "unable to walk a city block" due to the pain he is experiencing.The reporter then goes on state that he had not even been tested for metal allergy prior to implantation.The reporter states that he obtained a second opinion on his potential allergy only to find that he has an allergy to nickel as well as vanadium.

• Brand Name: FEMORAL STEM 36 NECK 20X15X165
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): DEPUY ORTHOPEDICS, INC.
• MDR Report Key: 6604296
• MDR Text Key: 76528211
• Report Number: MW5070094
• Device Sequence Number: 5
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2017
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 523794
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 122