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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OSS MODULAR PROXIMAL TIBIA 9CM 63MM STANDARD PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS OSS MODULAR PROXIMAL TIBIA 9CM 63MM STANDARD PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. (b)(4). The device was not returned, however, other samples and manufacture records were reviewed and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components. Corrective action has been initiated to address the reported issue.
 
Event Description
It was reported that the label of the modular proximal tibia has a discrepancy in the description.
 
Manufacturer Narrative
This complaint is recorded with zimmer biomet under (b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Review of the dhr found a related anomaly:and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components. Investigation results concluded that the reported event was due to an error in the global label process. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that he label of the modular proximal tibia has a discrepancy in the description. Additional information received noted the device was not needed and the procedure was completed without delay.
 
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Brand NameOSS MODULAR PROXIMAL TIBIA 9CM 63MM STANDARD
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6251903
MDR Text Key64896655
Report Number0001825034-2017-00181
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK083827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP113462
Device Lot Number539760
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2015
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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