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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MAESTRO RADIAL STEM 4.5X40MM PROSTHESIS SHOULDER

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ZIMMER BIOMET, INC. MAESTRO RADIAL STEM 4.5X40MM PROSTHESIS SHOULDER Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (udi): n/a. Medical product: catalog #: 180151, maestro rad w/brg 7x15 7. 5 rt, lot # 922440; catalog #: 180351, variable lock screw 4. 75x20mm, lot # 748570; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180352, variable lock screw 4. 75x25mm, lot # 551330; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180321, maestro tc capitatestem 6x15mm, lot # 238690. The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not. Once this information is obtained a follow-up mdr will be submitted. 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. Unknown if product will be returned.
 
Event Description
It was reported that the patient is scheduled to be getting a revision due to the radial stem being loose in the canal.
 
Manufacturer Narrative
(b)(4). Reported event was considered confirmed due to the proved x-rays that showed loosening of the radial component. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was considered to be user error as it was known that the patient was a nurse that lifted patients. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05314.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameMAESTRO RADIAL STEM 4.5X40MM
Type of DevicePROSTHESIS SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9130210
MDR Text Key165315140
Report Number0001825034-2019-04291
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
PMA/PMN Number
K042032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberN/A
Device Catalogue Number180180
Device Lot Number181430
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/27/2019 Patient Sequence Number: 1
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