MAUDE Adverse Event Report: ZIMMER INC. VERSYS ML TAPER STEM; PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / CERAMIC/POLYMER

Catalog Number 8018-32-02

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Swelling (2091); Thyroid Problems (2102); Tinnitus (2103); Visual Impairment (2138); Dizziness (2194); Anxiety (2328); Ambulation Difficulties (2544); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

In 2005 zimmer versys system with m/l taper stem, i am suffering pain, swelling, lump.Vision, hearing, heart, progeria, thyroid, tinnitus, and no longer can walk, and new symptoms everyday.Nausea, dizzy, depression, anxiety, need revision asap.

• Brand Name: VERSYS ML TAPER STEM
• Type of Device: PROSTHESIS, HIP, SEMI - CONSTRAINED, METAL / CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER INC. ; 345 e. main st.; warsaw IN 46580
• MDR Report Key: 7872700
• MDR Text Key: 120287873
• Report Number: MW5079784
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Report Date: 09/11/2018

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8018-32-02
• Device Lot Number: 60332948
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 48 YR