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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Noise, Audible (3273)
Patient Problems Arthritis (1723); Fall (1848); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)
Event Date 12/19/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown bearing, catalog #: unk, lot #: unk, unknown femoral, catalog #: unk, lot #: unk. Customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. When the investigation is complete, a follow-up report will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06797, 0001822565-2018-06798, 0001822565-2018-06799. 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. Device remains implanted in patient.

 
Event Description

It was reported that patient underwent right total knee arthroplasty. Subsequently, patient is experiencing pain, problems walking, back and sciatica issues, loosening, and plate too large for patient.

 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED 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 Key8152091
MDR Text Key129959749
Report Number0001822565-2018-06799
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532006702
Device LOT Number63492613
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 Received09/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/14/2016
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: 12/11/2018 Patient Sequence Number: 1
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