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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 13MM X 460MM; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. HFN RH 125 DEG 13MM X 460MM; PROSTHESIS, KNEE Back to Search Results
Catalog Number 814313460
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034-2019-02758.0001825034-2019-02759.Udi: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
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Brand Name
HFN RH 125 DEG 13MM X 460MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8734216
MDR Text Key149187959
Report Number0001825034-2019-02757
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number814313460
Device Lot Number785410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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