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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE C LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. DISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE C LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Fever (1858); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Ambulation Difficulties (2544)
Event Date 02/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was confirmed by review of medical records and analysis of returned device. The poly components showed minimal signs of wear. Measured dimensions were conforming to print specification. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined. 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. Concomitant medical products - stem collar 35 mm o. D. , catalog #: 00585204035 lot #: 63284526, tibial block and screws precoat size 2 5 mm thickness, catalog #: 00598800226 lot #: 63168114, stem extension straight 11mm dia x 100mm length, catalog #: 00598801011 lot #: 63451500, palacos r+g 1x40, catalog #: 66022663 lot #: 86604591, fluted stem extension straight precoat, catalog #: 00585205011 lot #: 63574485, tibial component precoat size 2, catalog #: 00588000200 lot #: 63696269, tibial block and screws precoat size 2. 5 mm, catalog #: 00598800226 lot #: 63281479, articular surface with segmental hinge post size c 14 mm height, catalog # 00585003014, lot # 62788895, polyethylene insert size c, catalog # 00585001395, lot # 63649607. Multiple reports have been submitted for this event. Please see associated reports: 0001822565 - 2018 - 01479, 0001822565 - 2018 - 01480, 0001822565 - 2019 - 00964, 0001822565 - 2019 - 00965.
 
Event Description
It was reported that the patient presented with swelling, discharge, fever and had reported recent falls. The patient was then revised to address an infection. It was further reported through patient's medical records that the patient was noted to have pji and haemarthrosis which was likely haematologically seeded. Patient also reported to have itchy macular rash. Furthermore, the pus culture was (b)(6) and therefore, the patient was started on antibiotics. Finally, it was noted the patient is using a cane to ambulate. Attempts have been made and no further information has been provided.
 
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Brand NameDISTAL FEMORAL COMPONENT FOR CEMENTED USE ONLY IN THE USA SIZE C LEFT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8380338
MDR Text Key137502751
Report Number0001822565-2019-00964
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00585001301
Device Lot Number63588147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/28/2019 Patient Sequence Number: 1
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