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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 12/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Complaint sample was evaluated and the reported event was confirmed. All explanted devices were returned, and cement was found on the tibia, and wear on the articular surface. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Per package inserts: wear and loosening are known adverse effect of this system. The wear in the poly might cause the tibia to loose as stated in the reported event. However, sufficient information was not provided to identify the cause of the articular surface wear. Therefore, a definitive root cause cannot be determined. 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. Concomitant medical products: 42522200613, articular surface, lot # 63057860; 42502806802, femur, lot # 63351597. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00727.
 
Event Description
It was reported that the patient underwent a revision of the knee due to tibial loosening and poly wear. Attempts have been made and no further information has been provided.
 
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Brand NameTIBIA CEMENTED 5 DEGREE STEMMED RIGHT
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 Key9167200
MDR Text Key161565200
Report Number3007963827-2019-00287
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42532007902
Device Lot Number63656203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2017
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: 10/08/2019 Patient Sequence Number: 1
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