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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA THE PERSONALIZED KNEE SYSTEM FEMUR TRABECULAR METAL CRUICIATE RETAINING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA THE PERSONALIZED KNEE SYSTEM FEMUR TRABECULAR METAL CRUICIATE RETAINING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: persona uc articular surface, catalog #: 42511200412, lot #: 63551546; persona tibia, catalog #: 42532006401, lot #: 63744321; prolong nexgen patella, catalog #: 00597206626, lot #: 62257588; palacos r 1x40 single, catalog #: 00111214001, lot #: 87494700; palacos cement, catalog #: unknown, lot #: unknown. Customer has indicated product will not be returned as product remains implanted. The investigation is in process. Once the investigation is completed, a follow-up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00846, 3007963827-2019-00056, 0001822565-2019-00847, 0001822565-2019-00848. 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. Device remains implanted in patient.

 
Event Description

It was reported patient underwent left total knee arthroplasty. Subsequently, patient is experiencing difficulty walking, pain and a burning sensation. No revision procedure has been reported to date.

 
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Brand NamePERSONA THE PERSONALIZED KNEE SYSTEM FEMUR TRABECULAR METAL CRUICIATE RETAINING
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 Key8369489
MDR Text Key137118650
Report Number0001822565-2019-00847
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502205601
Device LOT Number63417242
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/21/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/19/2016
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: 02/26/2019 Patient Sequence Number: 1
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