MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SOLUTION; PROSTHESIS, HIP

Device Problems Fracture (1260); Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Necrosis (1971); Pain (1994); Reaction (2414); Ambulation Difficulties (2544)

Event Date 05/05/2014

Event Type  Injury  

Event Description

The patient has bilateral hip replacements due to avascular necrosis following a severe allergic reaction and subsequent steroid use.The patient had a sudden onset of pain that led him to inability to ambulate, and was seen at an external emergency room where he was diagnosed with a periprosthetic femur fracture (the report and x-rays are unavailable for review).He subsequently reported to the hospital because he was unable to reach his ortho surgeon from the external facility.He was then seen by the orthopaedic surgery service, who diagnosed him with a periprosthetic femur fracture with a fractured femoral stem.He was then revised here.The proximal portion of the femoral stem, as well as femoral head and acetabular components were sent to us for analysis.Since we did not have both portions of the stem, and the patient had requested the device back, therefore limiting our ability to do destructive analysis, analysis was limited.Further, x-rays of the fracture were not available in the emr system, making it impossible to determine whether the stem fractured at the site of bone fracture.Light microscopy was undertaken to view the fracture surface.Sem was not undertaken because the patient requested that the implant be returned and sem analysis would have been destructive.There may have been an adjacent femur fracture that contributed to fatigue of the metal, but without radiographs of the fractured stem it is difficult to comment on the cause of the stem fracture.

• Brand Name: SOLUTION
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46581
• MDR Report Key: 3918268
• MDR Text Key: 21243395
• Report Number: 3918268
• Device Sequence Number: 1
• Product Code: JDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 122