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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA SINGLE INCH PEG PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PATELLA SINGLE INCH PEG PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign country: (b)(6). Concomitant medical products: unknown femoral component, unknown tibial tray, unknown tibial bearing. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. 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 event, please see associated reports: 0001825034-2019-04015, 0001825034-2019-04016.
 
Event Description
It was reported patient experienced knee dislocation and implant fracture. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NamePATELLA SINGLE INCH PEG
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 Key8975987
MDR Text Key158201665
Report Number0001825034-2019-04014
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K945028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/29/2022
Device Model NumberN/A
Device Catalogue Number11-150828
Device Lot Number556840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2017
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

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