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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR PROSTHESIS, KNEE

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ZIMMER, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Blood Loss (2597)
Event Date 06/21/2017
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 as no were trends identified. Per the persona package insert soft tissue damage and delayed wound healing are listed as known potential adverse effects. 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.
 
Manufacturer Narrative
(b)(6). The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.
 
Event Description
It was reported that the patient underwent a revision surgery due to hematoma and bleeding following initial knee arthroplasty approximately one (1) month prior. Attempts to obtain additional information are in progress, however no further information is available at this time.
 
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Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR
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 Key6730969
MDR Text Key134617649
Report Number0001822565-2017-04946
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Model NumberN/A
Device Catalogue Number42512600716
Device Lot Number62886005
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2014
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: 07/21/2017 Patient Sequence Number: 1
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