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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PLATE; PLATE, FIXATION
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ZIMMER BIOMET, INC. UNKNOWN PLATE; PLATE, FIXATION Back to Search Results
Catalog Number UNKNOWN PLATE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.[(b)(4)].
 
Event Description
The study reported thirteen patients who experienced limited rom postoperatively.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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.
 
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Brand Name
UNKNOWN PLATE
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8151642
MDR Text Key129960255
Report Number0001825034-2018-11197
Device Sequence Number1
Product Code HRS
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN PLATE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN SCREW; UNKNOWN SCREW
Patient Outcome(s) Other;
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