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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE KNEE PROSTHESIS

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ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE KNEE PROSTHESIS Back to Search Results
Catalog Number 42512000510
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Tibia cemented 5 degree stemmed left size f catalog# 42532007501, lot 62770871, all poly patella cemented 32 mm diameter catalog# 42540000032, lot# 62637762, femur cemented cruciate retaining (cr) standard left size 8 catalog# 42502606401, lot# 62688531. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2017-00305, 0001822565-2017-03310, 0002648920-2016-00960. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. 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
It is reported that the patient is experiencing unknown difficulties with a left total knee arthroplasty post-operatively. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE
Type of DeviceKNEE PROSTHESIS
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 Key6570801
MDR Text Key75305696
Report Number0001822565-2017-03309
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number42512000510
Device Lot Number62736894
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/16/2017 Patient Sequence Number: 1
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