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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL STEM; PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN HUMERAL STEM; PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Disassembly (1168); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr¿s were submitted for this event.Please see report: 0001822565 - 2017 - 06644, 0001822565 - 2017 - 06646.Concomitant medical products: ulna stem; part, lot unknown, humeral stem; part, lot unknown.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 is being considered for a revision for unknown reasons at an unknown time.No further information has been made available.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the xrays showed axial failure with a disassociated washer.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.
 
Event Description
It was reported the patient revised due to hardware loosening.
 
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Brand Name
UNKNOWN HUMERAL STEM
Type of Device
PROSTHESIS, 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 Key6891828
MDR Text Key87293822
Report Number0001822565-2017-06644
Device Sequence Number1
Product Code JDB
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 distributor,health profession
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/27/2017
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 Physician
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/30/2017
Initial Date FDA Received09/25/2017
Supplement Dates Manufacturer Received11/27/2017
Supplement Dates FDA Received11/28/2017
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) Hospitalization; Required Intervention;
Patient Age54 YR
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