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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER FEMORAL HEAD
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ZIMMER FEMORAL HEAD Back to Search Results
Catalog Number 8018-32-02
Device Problems Corroded (1131); Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); Reaction (2414)
Event Date 11/05/2007
Event Type  No Answer Provided  
Event Description
Problem: a failed totally hip arthroplasty may be caused by mechanically assisted crevice corrosion or macc.This occurs at the metal/metal modular junction in a total hip arthroplasty and has serious consequences such as adverse local tissue reaction (altr) in patients with metal-on-polyethylene total hip replacement.This patient had characteristics of macc.This clinical complication is extremely concerning because of both the high volume of hip replacements worldwide as well as the extensive soft tissue damage that can occur with severe reactions.(b)(6) procedure: right anterolateral tha.Diagnosis: djd.Lot #: 60629168, edi: (b)(4), ref: (b)(4), shell with cluster holes porous, trabecular metal modular acetabular system; lot #: 60786317, edi: (b)(4), ref: (b)(4), bone screw: self-tapping.; lot #: 60741731, edi: (b)(4), ref: (b)(4), trilogy acetabular system.
 
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Brand Name
FEMORAL HEAD
Type of Device
FEMORAL HEAD
Manufacturer (Section D)
ZIMMER
MDR Report Key7218751
MDR Text Key98308689
Report NumberMW5074862
Device Sequence Number2
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 01/24/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number8018-32-02
Device Lot Number60780515
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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