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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Aortic Valve Stenosis (1717); Chest Pain (1776); Myocardial Infarction (1969)
Event Date 09/02/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products ¿ orthopedic salvage system femoral bushings 2pk catalog #: 150477 lot #: 250110, orthopedic salvage system porous coated straight im stem 16. 5mm x 150mm catalog #: 150451 lot #: 785670, orthopedic salvage system resurfacing porous coated femoral component 5cm right catalog #: 150352 lot #: 121720, orthopedic salvage system yoke catalog #: 150493 lot #: 122870, orthopedic salvage system locking pin catalog #: 150478 lot #: 233570, orthopedic salvage system 71mm modular tibial base with plug catalog #: 150422 lot #: 140340, orthopedic salvage system tibial bushing catalog #: 150476 lot #: 180710, orthopedic salvage system porous coated im stem with screw 14. 5mm x 90mm, orthopedic salvage system 22mm tibial bearing catalog #: 150415 lot #: 982670, orthopedic salvage system axle catalog #: 150480 lot #: 407180, vanguard series a standard patella 37mm x 10mm catalog #: 184768 lot #: 533400. It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices currently remain implanted. 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 event; please see all reports associated with this event: 0001825034-2018-08744, 0001825034-2018-08745, 0001825034-2018-08746, 0001825034-2018-08747, 0001825034-2018-08748, 0001825034-2018-08749, 0001825034-2018-08750, 0001825034-2018-08751, 0001825034-2018-08752, 0001825034-2018-08753, 0001825034-2018-08754, 0001825034-2018-08755. Device remains implanted.

 
Event Description

It is reported that the patient developed bilateral pulmonary emboli one day following right knee arthroplasty. The patient was monitored at the hospital and was given xarelto and bed rest for treatment. The patient was discharged six days following the procedure after the surgeon felt his condition was stable. No additional patient consequences were reported.

 
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Brand NameBIOMET SUTURE BUTTON SINGLE ¼ INCH PEG WITH WIRE 37MM X 10MM
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 Key7860020
MDR Text Key119678305
Report Number0001825034-2018-08746
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK153657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2017
Device MODEL NumberN/A
Device Catalogue Number11-150863
Device LOT Number156460
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 Received07/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2012
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: 09/10/2018 Patient Sequence Number: 1
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