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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location is unknown.
 
Event Description
It was reported that the device fractured while trialing during procedure.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch. Customer has indicated that the product will not be returned because it was discarded. The investigation is in process. Once the investigation  has been completed, a follow-up mdr will be submitted. Updated: correction: should be reported as (b)(6)2018 in mdr # 0001822565-2018-06691 other text : discarded.
 
Event Description
No additional information received.
 
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Brand NamePERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL
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 Key8130558
MDR Text Key129247950
Report Number0001822565-2018-06691
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527600510
Device Lot Number62342528
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 Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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