• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)
Event Date 12/10/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Item # 42502606602 lot # 62945429, item # 42532007502 lot # 63078128, item # 42540000032 lot # 63104082. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00196, 0002648920-2019-00454, 0002648920-2019-00479. Reported event was confirmed by review of medical records. Medical records were provided and reviewed by a health care professional. Review of the available records identified the following: primary surgical note was provided and found no complication. The office visit notes states that there is a delay in the healing wound. Device history record was reviewed and no discrepancies were found. No product was returned; visual and dimensional evaluations could not be performed. A definitive root cause cannot be determined. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted. 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.

 
Event Description

It was reported that approximately one month post implantation, a patient required medical treatment due to delayed wound healing. The patient was treated with wet to dry wound dressings during a post operative office visit. Attempts have been made and no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 10 MM HEIGHT
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 Key8739081
MDR Text Key149337646
Report Number0002648920-2019-00455
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42521000510
Device LOT Number62846474
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 Received09/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2014
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: 06/27/2019 Patient Sequence Number: 1
-
-