MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH AND NEPHEW GENESIS II; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problems Break (1069); Degraded (1153); Unintended Movement (3026)

Patient Problems Fatigue (1849); Pain (1994); Abdominal Distention (2601); Joint Laxity (4526); Metal Related Pathology (4530); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2019

Event Type  Injury  

Event Description

I was fitted with a smith and nephew genesis ii tkr in (b)(6) 2016.In october 2018, it became unstable and painful.In (b)(6) 2019 it was diagnosed as a displaced bearing insert.During revision surgery in (b)(6) 2019 it was found that the bearing insert had become displaced, broken, and considerable wear of the zr femoral component had taken place where it was rubbing against the titanium tibial insert.Since the failure took place, i have developed numerous symptoms including skin problems (open sores and blisters), pain and fatigue, abdominal swelling, lipomas and various other auto-immune type conditions which i believe to be caused by the metallosis from the debris.More recently, in (b)(6) 2022, it was determined that the levels of zr in my blood were 10 times higher than a normal mom implant patient (in people without implants, zr is undetectable) which would extrapolate back to 100 times higher than normal at the time of the revision.Fda safety report id# (b)(4).

• Brand Name: SMITH AND NEPHEW GENESIS II
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 14408086
• MDR Text Key: 291833859
• Report Number: MW5109699
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DULOXETINE; MELOXICAM ; PARACETAMOL
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White