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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ZIMMER, FEMORAL HEAD
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ZIMMER ZIMMER, FEMORAL HEAD Back to Search Results
Model Number SEE ATTACHED
Device Problems Corroded (1131); Patient-Device Incompatibility (2682)
Patient Problems Foreign Body Reaction (1868); No Code Available (3191)
Event Type  Injury  
Event Description
Mechanically assisted crevice corrosion (macc) occurs at the metal/metal modular junction in total hip replacements and can lead to adverse local tissue reaction in patients with metal-on-polyethylene total hip replacement.In summary, a single surgeon evaluated his database and determined a macc prevalence of 3.2% in a consecutive series of contemporary zimmer non-cemented femoral hip components followed for a minimum of 6 months.This clinical complication is worrisome because of both the high volume of hip replacement worldwide and the soft tissue damage that can occur with severe reactions.See referenced report numbers mw5068755, mw5068756, mw5068757, mw5068758, mw5068759, mw5068760, mw5068761, mw5068762, mw5068763, mw5068764, mw5068765, mw5068767, mw5068768, mw5068769, mw5068770, mw5068771, mw5068772, mw5068773, mw5068774, mw5068775, mw5068776, mw5068777, mw5068778, mw5068779, mw5068780, mw5068781.
 
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Brand Name
ZIMMER, FEMORAL HEAD
Type of Device
ZIMMER, FEMORAL HEAD
Manufacturer (Section D)
ZIMMER
warsaw IN
MDR Report Key6446814
MDR Text Key241267354
Report NumberMW5068766
Device Sequence Number2
Product Code KXA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
3 Devices were Involved in the Event: 1   2   3  
2 Patient was Involved in the Event
Date FDA Received03/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEE ATTACHED
Device Catalogue Number8018-32-02
Device Lot Number61452276
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Required Intervention;
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