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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR PROVISIONAL SHIM SIZE EF 12MM PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA CONSTRAINED TIBIAL ARTICULAR PROVISIONAL SHIM SIZE EF 12MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 42527900402
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Reference (b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the persona shim was found with missing ball bearings on an office shelf. No information regarding when or where these originally went missing. Attempts have been made and additional information on the reported event is unavailable at this time. No adverse events have been reported as a result of the malfunction.

 
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Brand NamePERSONA CONSTRAINED TIBIAL ARTICULAR PROVISIONAL SHIM SIZE EF 12MM
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 Key6591052
MDR Text Key75966368
Report Number0001822565-2017-03547
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42527900402
Device LOT Number62538388
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/25/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/03/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-1052-2015

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