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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA BEARING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. UNKNOWN PERSONA BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog #: 42532007102, tibia cemented 5 degree stemmed right size e, lot # 63490887, catalog #: unknown, persona femorals, lot # unknown. Reported event was unable to be confirmed due to limited information received from the customer. Device history record review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00007, 0001822565-2019-03980, 0001822565-2019-03981.
 
Event Description
It was reported that 20 months after their initial procedure the patient stated the tibia had failed. He experienced a 30 degree declination. Patient does not wish to give any further information.
 
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Brand NameUNKNOWN PERSONA BEARING
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 Key9069877
MDR Text Key160862279
Report Number0001822565-2019-03981
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/16/2019 Patient Sequence Number: 1
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