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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL FULL BLOCK AUGMENT PRECOAT SIZE 5 10 MM THICKNESS PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. TIBIAL FULL BLOCK AUGMENT PRECOAT SIZE 5 10 MM THICKNESS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product has been returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a tibial augment was opened, and the inside package was damaged and the sterility was possibly compromised from the packaging being crushed. There is no additional information available.
 
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Brand NameTIBIAL FULL BLOCK AUGMENT PRECOAT SIZE 5 10 MM THICKNESS
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 Key12950918
MDR Text Key281938065
Report Number0001822565-2021-03451
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 Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00588000510
Device Lot Number62458114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2013
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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