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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA POLY PATELLA CEMENTED PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. PERSONA POLY PATELLA CEMENTED PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 08/07/2015
Event Type  Injury  
Manufacturer Narrative
Reported event was confirmed by review of operative reports. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. Therefore, it is highly unlikely that the specified device caused any patient infection. Per package insert nexgen cr,ps,cra,lps and lcck knee infection is one of the adverse effects of the tka procedure. 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)(4). Udi- (b)(4). Concomitant medical products: unknown nexgen knee bearing. Unknown nexgen knee femoral. Unknown nexgen knee tibial trays. Unknown nexgen knee stems. Unknown nexgen knee stems. Unknown bone cement. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Multiple mdr reports were filed for this event, please see associated reports:0001822565 - 2017 - 07999, 0001822565 - 2017 - 08000, 0002648920 - 2017 - 00717, 0001822565 - 2017 - 08001, 0001822565 - 2017 - 08002, 0001822565 - 2017 - 08003.
 
Event Description
It was reported that after a knee arthroplasty the patient underwent a right knee revision with all devices removed along with a synovectomy procedure due to infection. Antibiotic spacers were placed.
 
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Brand NamePERSONA POLY PATELLA CEMENTED
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7068117
MDR Text Key249538250
Report Number0002648920-2017-00717
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Model NumberN/A
Device Catalogue Number42540200032
Device Lot Number62734990
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 Received01/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/29/2017 Patient Sequence Number: 1
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