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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 07/13/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical product: natural tibia trabecular metal two-peg porous fixed bearing catalog # 42530007101 lot # 64517444; articular surface fixed bearing posterior stabilized (ps) catalog # 42512400712 lot # 64444699; all poly patella catalog # 42540000035 lot # 64621021. Customer has indicated that the product will not be returned because it remains implanted. Multiple mdr reports were filled for this event: 0001822565-2020-03044, 3007963827-2020-00202, 0002648920-2020-00386. Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management. Deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body. This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops. Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot. Even with the administration of preventive medication, dvt/blood clots can still develop. As the complaint indicated a post-operative complication developed and it can be implied medical intervention was required to treat the complication, therefore our complaint category, medical: procedure related would be appropriate. 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 the patient underwent an initial knee arthroplasty. Subsequently, the patient experienced acute pain and had a superficial deep vein thrombus (dvt). Patient was given medication, compression stockings and a foot pump/compression device to resolve the adverse event. Attempt for further information has been made, but no further information has been provided.

 
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Brand NameFEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS
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 Key10453938
MDR Text Key204367689
Report Number0001822565-2020-03041
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122745
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 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42500806401
Device LOT Number64524946
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 Received08/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2019
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: 08/26/2020 Patient Sequence Number: 1
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