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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT TM CR MONOBLOCK TIBIAL COMPONENT

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ZIMMER TMT TM CR MONOBLOCK TIBIAL COMPONENT Back to Search Results
Model Number N/A
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584)
Patient Problems Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Sepsis (2067)
Event Type  Injury  
Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification. Based on the information available, the root cause of the event cannot be determined. Should additional information be obtained to further this investigation, this report shall be updated. Device location unknown.

 
Event Description

It was reported that patient underwent unknown knee arthroplasty on (b)(6) 2015. About six weeks later, patient alleges severe pain and that knee felt loose and had to walk with a cane. Surgeon diagnosed pain as scar tissue and recommended chair device to break up scar tissue. Subsequently, patient saw new surgeon that suggested revision as patient's knee moved like a gear shift due to looseness and laxity. Patient was revised, revision surgery date is (b)(6) 2016. Some time after the revision, patient developed septic infection and felt that her knee sizing was incorrect.

 
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Brand NameTM CR MONOBLOCK TIBIAL COMPONENT
Type of DeviceTM CR MONOBLOCK TIBIAL COMPONENT
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 Key6720635
MDR Text Key80253248
Report Number3005751028-2017-00047
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK031462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2017
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 Number00588604310
Device LOT Number61785348
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2011
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 TREATMENT DATA
Date Received: 07/18/2017 Patient Sequence Number: 1
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