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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR-FLEX POR FEMORAL G-L PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. CR-FLEX POR FEMORAL G-L PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical product: unknown tibial tray, cat#: unknown lot#: unknown. Unknown bearing, cat#: unknown lot#: unknown. Unknown patella, cat#: unknown lot#: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07659, 0001822565-2017-07661. Remains implanted.

 
Event Description

It was reported that following an initial knee arthroplasty, the patient is experiencing an allergic reaction. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further actions are required. Per the package insert of the femoral component, metal sensitivity is listed as a known potential adverse effect; however. A definitive root cause cannot be determined with the information 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 NameCR-FLEX POR FEMORAL G-L
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 Key7000353
MDR Text Key90998765
Report Number0001822565-2017-07661
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK031061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2017
Device MODEL NumberN/A
Device Catalogue Number00595201705
Device LOT Number60641226
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/11/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/03/2017 Patient Sequence Number: 1
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