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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Patient Problem No Information (3190)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The following report is submitted to relay additional information. The reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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.
 
Manufacturer Narrative
(b)(4). Product is not returned to zimmer biomet. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the hair was found on the implant when sterile packaging was opened at the field. No adverse events have been reported as a result of the malfunction.
 
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Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC)
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 Key7102093
MDR Text Key248553830
Report Number0001822565-2017-08365
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
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 01/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberN/A
Device Catalogue Number42512200410
Device Lot Number63026155
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2015
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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