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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528); Separation Failure (2547); Loosening of Implant Not Related to Bone-Ingrowth (4002); Difficult or Delayed Separation (4044)
Patient Problems Necrosis (1971); Pain (1994); Swelling (2091); No Information (3190)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source- (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient was revised due to femoral loosening. There is no additional information available at this time.
 
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Brand NameFEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D RIGHT
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 Key11196432
MDR Text Key227736121
Report Number0001822565-2021-00192
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00588001402
Device Lot Number64230855
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/19/2021 Patient Sequence Number: 1
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