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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH UNK AVENIR STEM
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ZIMMER GMBH UNK AVENIR STEM Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 06/01/2014
Event Type  Injury  
Event Description
It was reported that a patient was implanted with an avenir stem (exact catalogue number unk) on unk date and was revised on unk date due to stem subsidence (around 1cm).
 
Manufacturer Narrative
The manufacturer did not receive the device, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).
 
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Brand Name
UNK AVENIR STEM
Type of Device
UNK AVENIR STEM
Manufacturer (Section D)
ZIMMER GMBH
sulzerallee 8
winterthur 8404
SZ  8404
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
5742676
MDR Report Key3934648
MDR Text Key4576340
Report Number9613350-2014-03667
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/01/2014
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2014
Initial Date FDA Received06/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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