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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT PROSTHESIS, ELBOW Back to Search Results
Catalog Number 00840009400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: humeral component size 4 cat# 00840004415 lot# 63257171. Humeral screw kit 2 humeral screws cat# 00840009000 lot# 63364033. Ulnar component size 4 cat# 00840002407 lot# 64083002. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00272, 0001822565-2020-00273, 0001822565-2020-00274.
 
Event Description
It was reported a patient underwent a right total elbow arthroplasty, ulnar decompression and anterior subcutaneous transposition, radial head excision. It was also reported the patient fell approximately 2 weeks later. No abnormal x-ray findings were noted at this visit. The patient had ongoing stiffness and slow progress with range of motion. Approximately 7 months after arthroplasty, a stress reaction in the medial column with minimal displacement was noted on x-ray. The patient was reportedly asymptomatic and implants were in correct placement. No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameNEXEL ARTICULATION KIT
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9627419
MDR Text Key178744163
Report Number0001822565-2020-00275
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840009400
Device Lot Number63991814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2020 Patient Sequence Number: 1
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