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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HUMERAL HEAD; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UNKNOWN HUMERAL HEAD; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional concomitant medical products: unknown humeral stem; unknown glenoid.The complaint is under investigation.Once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08089, 0001825034 - 2018 - 08090.
 
Event Description
It was reported that the patient underwent a left shoulder arthroplasty on an unknown date.Subsequently, patient has been indicated for a revision procedure due to unknown reasons.Attempts were made to gather information and no additional information is available at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event based on the additional information received, it was determined that this product is not related to the event.The initial report was submitted in error and should be voided.
 
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Brand Name
UNKNOWN HUMERAL HEAD
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7777994
MDR Text Key116932098
Report Number0001825034-2018-08088
Device Sequence Number1
Product Code MJT
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received09/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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