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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 KNEE INSTRUMENT

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 01/15/2018
Event Type  malfunction  
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 device fractured. Attempt for further information has been made, but no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay updated and additional information. Updated: additional: complaint sample was evaluated and the reported event was confirmed. Visual evaluation of returned constrained tibial articular surface provisional part 42-5276-005-05 lot 63245192 shows nicks and gouges with post feature fractured off. Sem analysis were performed and revealed fractured surface artifacts consistent with low cycle fatigue culminating in bending overload fracture. Dhr was reviewed and no discrepancies were found. Root cause was unable to 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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
The follow-up report is being submitted to relay additional information. 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.
 
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Brand NamePERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL
Type of DeviceKNEE INSTRUMENT
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 Key7355744
MDR Text Key103167450
Report Number0001822565-2018-01674
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527600505
Device Lot Number63245192
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2015
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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