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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. ULNAR COMPONENT PROSTHESIS, ELBOW Back to Search Results
Catalog Number 00840001507
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Peroneal Nerve Palsy (2362); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were reported for this event. Please also see associated reports: 0001822565 - 2019 - 01609; 0001822565 - 2019 - 01607; 0001822565 - 2019 - 01604. Primary udi# (b)(4). Concomitant medical products: part number lot code description; 00840004510 63287679 humeral stem; 00840009000 63610435 humeral screw; 00840001507 63175486 ulnar component; 00840009500 63570105 articulation kit. Report source: the event occurred in the (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Event Description
It was reported the patient experienced severe pain and disability secondary to post operative radial nerve palsy. The event was reportedly not device related, but related to the surgical procedure. No further information is available at this time.
 
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Brand NameULNAR COMPONENT
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 Key8523579
MDR Text Key142240329
Report Number0001822565-2019-01608
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840001507
Device Lot Number63175486
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 Received07/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/17/2019 Patient Sequence Number: 1
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