MAUDE Adverse Event Report: STRYKER ACCOLADE 2.5 STEM; TOTAL HIP REPLACEMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Rupture (2208); Skin Tears (2516); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Event Description

Patient reports severe pain and itching immediately after hip implant.Patient also reports sensitivity to her medications, ambulation difficulties, abnormal leg growth, white patches/dots all over her body, which she believes to be metallosis.Her leg veins have ruptured and at times felt like "glass is protruding" out of her legs causing her to bleed.Pt reports hearing clicks when she walks.She has since been diagnosed with behchts' auto-immune disease.She feels as though the implant has taken her life.Reporter believes she is implanted with a recalled device in which she was never given a notice from the mfr or dr.

• Brand Name: ACCOLADE 2.5 STEM
• Type of Device: TOTAL HIP REPLACEMENT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7713945
• MDR Text Key: 115009876
• Report Number: MW5078528
• Device Sequence Number: 1
• Product Code: LWJ
• 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

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 55