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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT PROSTHESIS, KNEE Back to Search Results
Catalog Number 42517600710
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2017
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The following sections were complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned provisional top identified that it had fractured on the medial side of the post. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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.
 
Manufacturer Narrative
(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 provisional fractured during a knee arthroplasty. No adverse events have been reported as a result of the malfunction.
 
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Brand NamePERSONA CPS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT
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 Key6692300
MDR Text Key134080271
Report Number0001822565-2017-04646
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 09/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number42517600710
Device Lot Number62518138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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