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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 SHIM; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2020
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 was discovered to have missing components.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 additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h9, h10.Complaint sample was evaluated.Visual examination of the returned device exhibited signs of repeated use and and have one of component disassembled / missing the components.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
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Brand Name
PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10362129
MDR Text Key201542905
Report Number0001822565-2020-02762
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42527900404
Device Lot Number63967648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received09/01/2020
Supplement Dates FDA Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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