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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Bacterial Infection (1735)
Event Date 01/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00730, 0001822565-2019-00731, 0001822565-2019-00732, 0001822565-2019-00733, 0001822565-2019-00734, and 0001822565-2019-00735. Concomitant medical devices: distal femoral xt component size b right catalog#: 00585004202 lot#: ni, segment with male/female taper 140 mm length catalog#: 00585004614 lot#: ni, segment with male/female taper 30 mm length catalog#: 00585004603 lot#: ni, articular surface with segmental hinge post size b 12 mm height catalog#: 00585002012 lot#: ni, stem extension straight 18mm dia x 100mm length catalog#: 00598801018 lot#: ni. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the devices. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent right knee arthroplasty. Subsequently, patient underwent irrigation, debridement, and replacement of components due to suspected infection and tibial loosening.
 
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Brand NameTIBIAL COMPONENT PRECOAT SIZE 4
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 Key8348509
MDR Text Key136492559
Report Number0001822565-2019-00734
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeNZ
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
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00588000400
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 Received12/05/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/18/2019 Patient Sequence Number: 1
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