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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET 360 TIBIAL CRUCIATE WING 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 BIOMET, INC. BIOMET 360 TIBIAL CRUCIATE WING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rheumatoid Arthritis (1724); Death (1802); Staphylococcus Aureus (2058)
Event Date 11/14/2018
Event Type  Death  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: series-a standard patella 34mm x 8. 5mm catalog #: 184766 lot #: 409610, biomet splined knee stem v2 with screw 18mm x 40mm catalog #: 148293 lot #: 269100, vanguard ssk 360 femoral component left 72. 6mm catalog #: 185287 lot #: 6053604, biomet 360 offset adapter with screws 7. 5mm catalog #: 185212 lot #: 289130, vanguard 360 revision posterior augment with bolt 5mm x 72. 5mm catalog #: 185347 lot #: 862360, vanguard 360 revision distal femoral augment with bolt 5mm x 72. 5mm catalog #: 185307 lot #: 186000, biomet 360 tibial tray 79mm catalog #: 185205 lot #: 883210, biomet 360 offset adapter 2. 5mm catalog #: 185210 lot #: 371710, biomet 360 tibial augment 10mm x 79mm catalog #: 185235 lot #: 830830, biomet splined knee stem v2 with screw 17mm x 40mm catalog #: 148292 lot #: 945540, vanguard posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 449000, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 237190, biomet tibial locking bar catalog #: 141205 lot #: 966260, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 055590, biomet tibial locking bar catalog #: 141205 lot #: 478950, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 018270, biomet tibial locking bar catalog #: 141205 lot #: 889430, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 018270, biomet tibial locking bar catalog #: 141205 lot #: 588070, tibial knee cement mold 80mm catalog #: 433180 lot #: 014870, femoral knee cement mold 70mm catalog #: 432170 lot #: 202630. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device remains unknown at this time. Review of the device history records identified no related deviations or anomalies during manufacturing. Review of the sterile certificates indicates that the products were sterile when they were released from zimmer biomet control. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2018-10745, 0001825034-2018-10746, 0001825034-2018-10747, 0001825034-2018-10748, 0001825034-2018-10749, 0001825034-2018-10750, 0001825034-2018-10751, 0001825034-2018-10752, 0001825034-2018-10753, 0001825034-2018-10754, 0001825034-2018-10755, 0001825034-2018-10756.

 
Event Description

It was reported the patient underwent left total knee arthroplasty and developed a (b)(6) infection three (3) weeks post-operatively. The patient underwent multiple polyethylene bearing replacements with irrigation and debridement procedures. As the infection continued, the patient underwent a knee arthroplasty revision and spacer molds were implanted. It was noted during the revision procedure that the patient had necrosis on the incision as well as the patella. Approximately three weeks later, the patient underwent a below the knee amputation. Six days following the amputation, the patient exhibited rheumatoid arthritis in the lungs, a decrease in vital signs and expired.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOMET 360 TIBIAL CRUCIATE WING
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 Key8086295
MDR Text Key127675840
Report Number0001825034-2018-10752
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number185651
Device LOT Number700880
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 Received08/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2017
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: 11/19/2018 Patient Sequence Number: 1
-
-