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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT NEXGEN TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT SIZE 4 C-H; PROSTHESIS, KNEE

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ZIMMER TMT NEXGEN TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT SIZE 4 C-H; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994); Swelling (2091); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen porous femoral component size d right, catalog #: 00597201402, lot #: 62685909.Nexgen trabecular metal standard primary patella 32mm, catalog #: 00587806532, lot #: 62767097.The device was evaluated through manufacturing review, however, the reported event could not be confirmed with the information provided.The device history records were reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could be determined due to limited information received from the customer.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2018-04594, 3005751028-2020-00028.This complaint has been reassessed as part of ca-(b)(4).It was determined that additional regulatory reporting is required.
 
Event Description
It is reported that the patient has experienced pain, swelling, numbness and loss of balance, which has led to multiple falls approximately three (3) years following knee arthroplasty.Attempts have been made and no additional information is available.
 
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Brand Name
NEXGEN TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT SIZE 4 C-H
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer (Section G)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer Contact
william hara
10 pomeroy road
parsippany, NJ 07054
9735760032
MDR Report Key9992910
MDR Text Key189148570
Report Number3005751028-2020-00032
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2016
Device Model NumberN/A
Device Catalogue Number00588604414
Device Lot Number61769569
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/25/2018
Initial Date FDA Received04/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2011
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 Sequence Number1
Patient Outcome(s) Other;
Patient Weight100
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