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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of the returned part indicates that the dovetail was compressed from one side and flared on the other. Nicks and gouges were found onto the inferior surface. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Due to the fact that the dovetail feature is compressed and flared, it seems that proper surgical technique was not followed during inserting the articular surface. Therefore, the root cause of the reported issue is attributed to user error. 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.
 
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 3500a will be submitted. 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.
 
Event Description
It was reported that the returned device showed evidence of deformed dovetail which would prevent proper seating of the articular surface on the tibial component.
 
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Brand NamePERSONA HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6829287
MDR Text Key249621017
Report Number0001822565-2017-06128
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue Number42512401013
Device Lot Number63119909
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
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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