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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN ROTATING HINGED KNEE TIBIAL BEARING 12MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FINN ROTATING HINGED KNEE TIBIAL BEARING 12MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implanted 1997. Concomitant devices -kne-finn-bearings- unk catalog # n/i lot #: 092610, finn yoke std reinforced catalog #: 153865 lot #: 377520. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034 - 2021 - 02813; 0001825034 - 2021 - 02812, investigation incomplete.
 
Event Description
It was reported that a knee revision was performed approximately 24 years post operatively due to implant wear and fracture. Attempts have been made and no further information has been provided.
 
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Brand NameFINN ROTATING HINGED KNEE TIBIAL BEARING 12MM
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 Key12577620
MDR Text Key274829685
Report Number0001825034-2021-02812
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2002
Device Model NumberN/A
Device Catalogue Number153982
Device Lot Number092610
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 Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/1997
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: 10/05/2021 Patient Sequence Number: 1
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