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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOID; SHOULDER PROSTHESIS
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ZIMMER BIOMET, INC. UNKNOWN GLENOID; SHOULDER PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Erosion (1750)
Event Type  Injury  
Manufacturer Narrative
(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
 
Event Description
It was reported that the patient is scheduled for a revision procedure due to bone loss.
 
Event Description
This complaint was reported under the incorrect manufacturing site.It will be further investigated on mdr# 0001825034-2019-05431.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.This complaint was reported under the incorrect manufacturing site.It will be further investigated on medwatch#: 0001825034-2019-05431.
 
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Brand Name
UNKNOWN GLENOID
Type of Device
SHOULDER PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8934596
MDR Text Key155638352
Report Number0001822565-2019-03654
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/03/2019
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/01/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received11/25/2019
Supplement Dates FDA Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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