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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CR VE ARTICULAR SURFACE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA CR VE ARTICULAR SURFACE 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); Neck Stiffness (2434); Limited Mobility Of The Implanted Joint (2671)
Event Date 05/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number: 42502006402 lot number: 62763632 brand name: persona cr narrow femoral. Catalog number:42532006702 lot number:63125357 brand name: persona stemmed. Catalog number:42540000032 lot number:63064362 brand name: persona all poly. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06673, 0001822565-2018-06674, 0001822565-2018-06676. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Event Description
It was reported that the patient is suffering from pain, stiffness and limited activity in daily life approximately 2 years post initial surgery. The surgeon stated this was not related to the device. No revision occurred, implant remains in patient. Attempt for further information has been made, but no further information has been provided.
 
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Brand NamePERSONA CR VE ARTICULAR SURFACE
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 Key8124439
MDR Text Key129039372
Report Number0001822565-2018-06675
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
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 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Model NumberN/A
Device Catalogue Number42522000412
Device Lot Number62342598
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 Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2013
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

Patient Treatment Data
Date Received: 12/03/2018 Patient Sequence Number: 1
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