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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT SIZE D RIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT SIZE D RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices - nexgen rotating hinge knee articular surface catalog #: 00588004012 lot #: 64382844, nexgen all poly patella standard size 35 catalog #: 00597206535 lot #: 64325356, nexgen straight stem extension 11mm x 100mm catalog #: 00598801011 lot #: 64413907, nexgen straight stem extension 13mm x 1000mm catalog #: 00598801013 lot #: 64454566, nexgen precoat tibial component size 3 catalog #: 00588000300 lot #: 64393895 report source - foreign: (b)(6). The product was evaluated through manufacturing review, however, the reported event could not be confirmed. The device history records were reviewed and no discrepancies were identified. A definitive root cause could not 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. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2020-02382.
 
Event Description
It is reported that the patient underwent a knee arthroplasty revision to address pain and unscrewing of the hinge prosthesis. Attempts have been made and no additional information is available.
 
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Brand NameNEXGEN ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT 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 Key11096675
MDR Text Key224430809
Report Number0001822565-2020-04263
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 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
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 Received03/01/2021
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: 12/30/2020 Patient Sequence Number: 1
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