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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NEXEL VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT ELBOW PROSTHESIS

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ZIMMER, INC. ZIMMER NEXEL VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT ELBOW PROSTHESIS Back to Search Results
Catalog Number 00840009400
Device Problem Component Incompatible (1108)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. Concomitant medical products: catalog #00840004410, zimmer nexel plasma sprayed humeral component, lot #63313335; catalog #00840001407, zimmer nexel plasma sprayed ulnar component, lot #63169548.
 
Event Description
It was reported that the axle pin and ulnar bearings were not able to be assembled with the ulnar component during elbow arthroplasty. No further information is available.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. No devices or photos were returned for evaluation. The device history records were reviewed for the pin and bearings with no deviations or anomalies being identified. This device is used for treatment. The complaint history review was conducted for the devices and found no additional complaints for the same lots. Surgical technique and notes were not provided. A definitive root cause of the reported issue cannot be determined with the information provided.
 
Manufacturer Narrative
This follow up report is being submitted to relay additional information. Dhr was reviewed and no discrepancies relevant to the reported event were found. The complaint sample was evaluated and the reported event could not be confirmed as no issues were identified. The articulation kit was received and the axle pin and ulnar bearings were able to assemble with the ulna component, contradictory to the reported event. A root cause was unable to be determined as device analysis indicated that the device met specification and the complaint could not be substantiated.
 
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Brand NameZIMMER NEXEL VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT
Type of DeviceELBOW PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6210345
MDR Text Key63431272
Report Number0001822565-2016-04806
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number00840009400
Device Lot Number63076176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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