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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Cmp-(b)(4). Updated: reported event is considered confirmed as the returned tasp was fractured. Visual examination concludes that the returned device is fractured, tasp eexhibits signs of repeated use(nicked and gouged ) also has fractured on the medial side of the post. All pieces were returned. Fracture analysis of the tasp provisional revealed fracture surface artifacts consistent with bending overload fracture. Device history record was reviewed and no discrepancies were found. Per the instrument/provisional use and care package insert, instruments should be carefully inspected before each use and should not be used if the instruments are marred or worn. The package insert also states that breakage can occur if the instruments are subjected to high loads or impactions. The root cause is considered to be operational context as the device was difficult to disassemble due to being jammed with tissue from use. 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
No further event information available at the time of this report.
 
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 while disassembling the jammed articular surface construct the technician fractured the base of articular surface.
 
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Brand NamePERSONA CONSTRAINED 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 Key7150232
MDR Text Key132785901
Report Number0001822565-2017-08687
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK123459
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 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42517600707
Device Lot Number62836961
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2014
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

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