MAUDE Adverse Event Report: STRYKER/HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEADICS ACCOLADE II HIP REPLACEMENT; PROSTHESIS, HIP

Model Number SEVERAL NUMBERS I HAVE PRINTOUT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Inflammation (1932); Burning Sensation (2146); Reaction (2414); Sweating (2444); Weight Changes (2607)

Event Date 07/01/2017

Event Type  Injury  

Event Description

I had stryker ii accolade hip replacements (b)(6) 2017 and (b)(6) 2017.About 3 months after the implants i got bursitis in both hips, gained 25 pounds, had extreme fatigue, my kidney levels started rising, had cold hands and feet, burning sensation in both legs, night sweats.I believe i am having an allergic reaction to metal components in the screws since i am highly allergic to nickel (even trace amounts like a peanut allergy) i had the melisa blood test before and after the surgery and it shows very high levels of nickel, molybdenum and manganese which i am allergic to and are in screws.I question why there are more screws in left hip vs right hip and you have more pain in left hip.I often cannot put weight on that leg.Doctor was very aware of my metal sensitivity to nickel and zirconium yet i believe they are in bone screws.Fda safety report id # (b)(4).

• Brand Name: ACCOLADE II HIP REPLACEMENT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): STRYKER/HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPEADICS
• MDR Report Key: 8655026
• MDR Text Key: 146835394
• Report Number: MW5086993
• Device Sequence Number: 1
• Product Code: MEH
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SEVERAL NUMBERS I HAVE PRINTOUT
• Device Catalogue Number: SEVERAL PARTS
• Device Lot Number: NOT SURE WHICH PART TO LIST
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 70