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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN ULNAR COMPONENT PROSTHESIS, EXTREMITY Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Atrial Fibrillation (1729)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) multiple mdr reports were filed for this event. Please also see associated report(s): 0001822565-2018-00955. Report source: literature- barco, r. , streubel, p. N. , morrey, b. F. , & sanchez-sotelo, j. (2017). Total elbow arthroplasty for distal humeral fractures. The journal of bone and joint surgery, 99(18), 1524-1531. Doi:10. 2106/jbjs. 16. 01222. Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. (b)(4). Not returned to manufacturer.
 
Event Description
It was reported in the journal article the patient experienced atrial fibrillation with pulmonary embolism. No further information has been made available at this time.
 
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Brand NameUNKNOWN ULNAR COMPONENT
Type of DevicePROSTHESIS, EXTREMITY
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 Key7292106
MDR Text Key100788427
Report Number0001822565-2018-00956
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/23/2018 Patient Sequence Number: 1
Treatment
UNKNOWN PART/LOT, HUMERAL STEM
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