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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. VERSYS PROVISIONAL FEMORAL HEAD
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ZIMMER, INC. VERSYS PROVISIONAL FEMORAL HEAD Back to Search Results
Catalog Number 00789503601
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2015
Event Type  malfunction  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported that during a hip procedure, the trial femoral head was stiff on the stem and difficult to remove.
 
Manufacturer Narrative
No devices were returned for further evaluation.No photos were received for further review; the condition of the components is unknown.Device history record review, complaint history review could not be performed as the lot codes of the devices are unknown.A potential field age and the frequency of use of these devices is unknown.It could not be confirmed if the provisionals were trialed in a compatible combination.Based on the information provided, a specific cause for the reported issue could not be determined.These (b)(4) design controlled devices are used for treatment.
 
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Brand Name
VERSYS PROVISIONAL FEMORAL HEAD
Manufacturer (Section D)
ZIMMER, INC.
po box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4834462
MDR Text Key15371093
Report Number1822565-2015-00871
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor,distributor,foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number00789503601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
VERSYS PROVISIONAL FEMORAL HEAD,; CATALOG #00789503602, LOT# UNK; CATALOG #00789503603, LOT# UNK
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