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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METALA CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT PROSTHESIS, KNEE

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ZIMMER TMT TRABECULAR METALA CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative

(b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 00597206529, all poly patella standard size 29 mm, lot # 64129660. 00575201506, cruciate retaining cr-flex gender solutions female femoral component, lot # 63058383. Report source: event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00169, 0001822565 - 2020 - 00901.

 
Event Description

It was reported that approximately 7 months post implantation, the patient developed an infection of the right knee arthroplasty. The patient underwent a washout of the knee. Subsequently, the patient has now been revised of the knee implants approximately 15 months post initial implantation due to septic loosening. Attempts have been made and no further information has been provided.

 
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Brand NameTRABECULAR METALA CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT
Type of DevicePROSTHESIS, 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 Key9824245
MDR Text Key189146209
Report Number3005751028-2020-00016
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK031462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00588604510
Device LOT Number63705140
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 Received06/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/09/2017
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: 03/12/2020 Patient Sequence Number: 1
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