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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE D PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE D PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 42502806002, femur, lot # 64278763, 42522100412, articular surface, lot # 63811402, 00587806535, patella, lot # 6425270. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00526, 3007963827 - 2020 - 00043.

 
Event Description

It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee. Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved. Attempts have been made and no further information has been provided.

 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE D
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 Key9681153
MDR Text Key178119469
Report Number0001822565-2020-00527
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530006702
Device LOT Number64102955
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 Received03/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/07/2020 Patient Sequence Number: 1
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