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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Thrombosis (2100)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: tibia cemented; p/n: 42532007902, l/n: 64019716; femur cemented; p/n: 42500606802, l/n: 63740573; articular surface fixed; p/n: 42522601012, l/n: 63512474; stem extension cemented; p/n: 42557000114, l/n: 63512474; all-poly patella cemented; p/n: 42540200038, l/n: 63761686. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains 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 associated reports: 0001822565 - 2018 - 06229, 3007963827 - 2018 - 00194, 0001822565 - 2018 - 06230. Remains implanted.

 
Event Description

It was reported a patient underwent initial total right knee arthroplasty two months post-implantation. Subsequently, the patient experience's a blood clot. No additional patient consequences were reported.

 
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Brand NameARTICULAR SURFACE FIXED BEARING
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 Key8046946
MDR Text Key126410102
Report Number0001822565-2018-06229
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522601012
Device LOT Number63512474
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 Received07/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/22/2016
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: 11/07/2018 Patient Sequence Number: 1
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