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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY HUMERAL STEM; PROTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY HUMERAL STEM; PROTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Pain (1994); Fracture, Arm (2351)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Date of event, unknown date, 2013.Concomitant medical products: unknown coonrad/morrey ulnar.Reported event was confirmed through receipt of doctor's office notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Doctor's office notes from (b)(6) 2013 state, (b)(6) female presents with complaint of pain in her left arm.During the first quarter of year 2013 the patient experienced a gastric bleed requiring a large amount of blood transfusions and icu hospitalization for a time period of one month.During this time the patient was apparently moved; lifted and transferred utilizing her left arm.When the patient regained consciousness she was experiencing extreme pain and notable deformity of her left arm.When patient stabilized, displaced fracture of distal humerus, implant failure was identified.Patient has remained immobilized with a removable long-arm splint; however, healing of the wound has delayed with patient still recovering from abdominal surgery.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.Report was initially submitted incorrectly under report number 0001825034-2017-06938.
 
Event Description
It is reported that patient presented to their doctor with elbow pain.The patient was treated with a cast.Review of doctor's office notes relay that the patient sustained a displaced distal humeral fracture with implant failure, following trauma.
 
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Brand Name
UNKNOWN COONRAD-MORREY HUMERAL STEM
Type of Device
PROTHESIS, 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 Key7172172
MDR Text Key96634864
Report Number0001822565-2018-00116
Device Sequence Number1
Product Code JDB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 01/05/2018
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? No
Device Operator Health Professional
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2018
Initial Date FDA Received01/08/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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