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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 Crack (1135)
Patient Problem No Information (3190)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
The reported event was confirmed as product was returned and visual examination concludes that the returned device exhibits signs of repeated use (nicked and gouged) also has fractured on the medial side of the post, all pieces were returned. Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations/ anomalies identified. Root cause could not be determined as frequency of use is unknown and condition of use is unknown. 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). 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.   discarded.
 
Event Description
It was reported that surgeon was performing a trial reduction of a persona total knee and the plastic poly provisional fractured.
 
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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
MDR Report Key7214714
MDR Text Key281002102
Report Number0001822565-2018-00368
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
PK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
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 Number63010198
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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