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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: femur trabecular metal cruciate retaining (cr) standard porous catalog#: 42502806401 lot#: 64635133; articular surface fixed bearing cruciate retaining (cr) left 10 mm height catalog#: 42502806401 lot#: 64635133. The device will not be returned for analysis, as its current location is unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that patient underwent a left knee revision approximately four months post-implantation due to tibial loosening. No bone in growth was seen on the explanted tibia component. No further information is available at this time.
 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F
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 Key11453405
MDR Text Key238858009
Report Number0001822565-2021-00651
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K173417
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 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42530007501
Device Lot Number64193713
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 Received04/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2019
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: 03/10/2021 Patient Sequence Number: 1
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