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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 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 Embolism (1829); Patient Problem/Medical Problem (2688)
Event Date 07/25/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products : item#:42502006402; femur cemented cruciate retaining (cr) lot#:64413839. Item#:42532007102; tibia cemented 5 degree stemmed lot#:64588474. Item#:42540000032; all poly patella cemented 32 mm diameter lot#:64775213. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00201, 3007963827-2020-00200, 0002648920-2020-00383. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management. If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs. This complication is called a pulmonary embolism. Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe. As the complaint indicated the patient developed a post-operative complication of dvt/pe, where medical intervention was completed to treat the pe.

 
Event Description

The patient was noted to have an acute pulmonary embolism on three days post-op, following a primary right unilateral total knee, requiring hospitalization and medical intervention.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 MM HEIGHT
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 Key10436957
MDR Text Key203850110
Report Number0001822565-2020-03006
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522100813
Device LOT Number64557921
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 Received08/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2019
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: 08/21/2020 Patient Sequence Number: 1
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