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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT SIZE 5/6; PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT SIZE 5/6; PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Tissue Damage (2104)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 00840002411 ulnar component plasma sprayed size 4 115 mm length right for cemented use only 63095903 00111314001 palacos rg 1x40 single 89904771 - qty 2, 211266 compr srs anti rot ic seg-30mm 351820, 110029939 compr srs 60mm dst hum bdy rt 588380, 211269 compr srs small flange 155830, 211230 compr srs mod stem -6x75mm 36590, 00111914001 palacos lvg 1x40 single 87014599.Customer has indicated that the product was not returned by the hospital.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 00748, 0001822565 - 2019 - 00756, 0001822565 - 2019 - 00754, 0001822565-2019-00766.
 
Event Description
It was reported that the patient underwent a revision surgery for the elbow and was subsequently revised for loosening and wound site complication (implant broke through the skin) two weeks post implantation.No additional information is available at this time.
 
Event Description
No additional information is available to report.
 
Manufacturer Narrative
The follow up report is being submitted to relay additional information received the complaint cannot be confirmed as no medical records were provided from the event.However it is stated that during this procedure since the patient had very little bone left the surgeon elected for off label use of the ulna component and implanted that component into the radius so he could reconstruct something.Patient had history of nonhealing, infection, multiple elbow traumas & surgeries.Per the 97-8401-002-00 rev.1 the ulnar component was intended to be implanted into ulna.Review of the device history records identified no related deviations or anomalies.The root cause of the reported issue is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
NEXEL ARTICULATION KIT SIZE 5/6
Type of Device
PROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8348515
MDR Text Key136502842
Report Number0001822565-2019-00678
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/21/2019
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? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Model NumberN/A
Device Catalogue Number00840009500
Device Lot Number63785438
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/21/2019
Initial Date FDA Received02/18/2019
Supplement Dates Manufacturer Received06/17/2019
Supplement Dates FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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