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U.S. Department of Health and Human Services

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

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ZIMMER, INC. PERSONA KNEE SYSTEM-ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Catalog Number 42522400711
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Joint Swelling (2356); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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 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 the associated 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
Reference: (b)(4). Implant date provide is (b)(6) 2015. Concomitant medical products: 42540200032, persona knee system all poly patella, lot 63038632 42500006202, persona knee system femur cemented posterior stabilized, lot 62970978 42532007102, persona knee system tibial cement stemmed component, lot 63080427. The investigation is in progress. Once the investigation has been completed, a follow up mdr will be submitted. Product is currently in situ. Multiple mdr reports were filed for this event with this being 1 of 4: 0002648920-2017-00259, 0002648920-2017-00260, 0001822565-2017-02695, 3007963827-2017-00213.
 
Event Description
It is reported that the patient is experiencing pain and swelling after a knee arthroplasty procedure in (b)(6) 2015. Patient is being tested for metal allergy. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NamePERSONA KNEE SYSTEM-ARTICULAR SURFACE
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 Key6513810
MDR Text Key134220487
Report Number0001822565-2017-02695
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 consumer,distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number42522400711
Device Lot Number6285720
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 Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/22/2017 Patient Sequence Number: 1
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