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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA VE ALL POLY PATELLA PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA VE ALL POLY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). :concomitant medical products persona articular surface fixed bearing ultracongruent (uc) right catalog # 42522200611 lot # 6395737, persona cr narrow femoral catalog # 42502007002 lot # 63512703, persona stemmed tibia catalog # 42532008302 lot # 63627453, headed screw 48 mm length catalog # 00579104100 lot # 63495278, headed screw 48 mm length catalog # 00579104100 lot # 63565449, headed screw 48 mm length catalog # 00579104100 lot # 63612132, headed screw 48 mm length catalog # 00579104100 lot # 63631220, psi psn pref cr pin guides psi psn pref cr pin guides catalog # 00597000033 lot # 17. 289116, psi psn pref cr pin guides psi psn pref cr pin guides catalog # 00597000033 lot # 17. 289666, 2. 5 mm female hex screw 25 mm length catalog # 42509902525 lot # 63649495, 2. 5 mm female hex screw 25 mm length catalog # 42509902525 lot #63649497. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001822565-2018-06987, 0001822565-2019-04032, 3007963827-2019-00267. The following sections could not be completed because the lot information could be: lot #: 63574821, expiration date: feb 28, 2022, manufacture date: mar 7, 2017. Or the lot # information could be: lot #: 63474786, expiration date: oct 31, 2021, manufacture date: oct 27, 2016. Discarded.
 
Event Description
It was reported the patient underwent a revision procedure due to infection and only the polyethylene articular surface was removed and replaced. Subsequently, the patient was revised again five days later due to infection and had all products, which were initially implanted approximately fifteen months prior, removed and replaced with antibiotic cement spacer molds.
 
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Brand NamePERSONA VE ALL POLY PATELLA
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9086088
MDR Text Key159174109
Report Number0001822565-2019-04034
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K121771
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue Number42540200038
Device Lot Number63574821
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2017
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: 09/19/2019 Patient Sequence Number: 1
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