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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 07/12/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 42502006202 - femoral component - 64578092. 42532006702 - tibial component - 64520988. 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 bilateral lower lobe pes that required hospitalization and medical intervention to treat the pes. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00207, 3007963827-2020-00208.

 
Event Description

It was reported that the patient had an initial right unilateral knee surgery. Approximately 24 days post implantation, the patient experienced a pulmonary embolism which required hospitalization for 8 days.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10472434
MDR Text Key204956590
Report Number3007963827-2020-00209
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 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522100412
Device LOT Number64379630
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 Received08/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/16/2019
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: 08/31/2020 Patient Sequence Number: 1
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