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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENT SHIELD HINGE SERVICE KIT SIZE D PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENT SHIELD HINGE SERVICE KIT SIZE D PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hematoma (1884); No Information (3190)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices - unknown nexgen femoral component, catalog #: ni, lot #: ni; unknown nexgen articular surface, catalog #: ni, lot #: ni. Report source - foreign: (b)(6). It is unknown at this time whether the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2019-00058, 0001822565-2019-00060. Investigation incomplete.
 
Event Description
It is reported that the patient underwent a right knee arthroplasty revision to address unknown complications post-operatively. It is unknown how long each device was implanted or which devices were replaced.
 
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Brand NameNEXGEN ROTATING HINGE KNEE CEMENT SHIELD HINGE SERVICE KIT SIZE D
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 Key8217645
MDR Text Key132091718
Report Number0001822565-2019-00059
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Model NumberN/A
Device Catalogue Number00585007514
Device Lot Number62103928
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 Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2012
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: 01/04/2019 Patient Sequence Number: 1
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