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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE F 12 MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE F 12 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667)
Patient Problems Failure of Implant (1924); No Code Available (3191); Hyperextension (4523)
Event Date 12/02/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported right knee arthroplasty and after 10 years was revised due to instability, hyperextension and fracture of the hinge or pe-sleeve. Attempts have been made and no further information has been provided.
 
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Brand NameARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE F 12 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 Key10987067
MDR Text Key220895471
Report Number0001822565-2020-04068
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2014
Device Model NumberN/A
Device Catalogue Number00588006012
Device Lot Number61222608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2009
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: 12/10/2020 Patient Sequence Number: 1
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