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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENT TAPER 60 MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. SEGMENT TAPER 60 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Femoral component item # 00585004202, lot # 63917932, multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02669.
 
Event Description
It was reported that a patient underwent an initial right knee procedure; subsequently, 11 months later the patient tripped over his walker and a revision was needed due to his segmental distal femoral component had broken off and the other was bent. This also caused the patient to be unstable. Attempts have been made, and no further information has been provided.
 
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Brand NameSEGMENT TAPER 60 MM
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 Key8744045
MDR Text Key149499329
Report Number0001822565-2019-02670
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585004606
Device Lot Number64036543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2018
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: 06/28/2019 Patient Sequence Number: 1
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