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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL NATURAL ACETABULAR CUP TM CUP

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ZIMMER TMT TRABECULAR METAL NATURAL ACETABULAR CUP TM CUP Back to Search Results
Catalog Number 00725504828
Device Problems Unstable; No Apparent Adverse Event; Migration
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative

Investigation in progress.

 
Event Description

Legal counsel for patient reported that patient underwent initial left hip procedure on (b)(6) 2011. Further the legal counsel reports that the patient underwent a reduction procedure due to pain and dislocation on (b)(6) 2018.

 
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Brand NameTRABECULAR METAL NATURAL ACETABULAR CUP
Type of DeviceTM CUP
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer (Section G)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer Contact
saurin patel
10 pomeroy road
parsippany , NJ 07054
9735760032
MDR Report Key8969838
Report Number3005751028-2019-00023
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2013
Device Catalogue Number00725504828
Device LOT Number60884455
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 Received04/27/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2008
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: 09/06/2019 Patient Sequence Number: 1
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