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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Code Available (3191)
Event Date 11/03/2017
Event Type  malfunction  
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Inspection of the returned device revealed that the dovetail feature is slightly flared all around and is also nicked and gouged. Device history record (dhr) was reviewed and no discrepancies were found. Root cause of the event could not be determined. 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). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the surgeon had difficulty inserting the bearing. He indicated that the groove on the lateral side of the bearing was not completed and was preventing the bearing from locking into the tibial tray. Surgery was completed with a different implant.
 
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Brand NamePERSONA ARTICULAR SURFACE FIXED 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 Key7103028
MDR Text Key253837669
Report Number0001822565-2017-08390
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2022
Device Model NumberN/A
Device Catalogue Number42512400510
Device Lot Number63756951
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2017
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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