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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS KNEE
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ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the inner package was discovered fractured and sterility compressed during revision procedure. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameTIBIAL COMPONENT PRECOAT SIZE 4
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 Key11236324
MDR Text Key228891797
Report Number0001822565-2021-00243
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue Number00588000400
Device Lot Number63595579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2017
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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