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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. COBALT G-HV BONE CEMENT 40G BONE CEMENT, ANITBIOTIC

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ZIMMER, INC. COBALT G-HV BONE CEMENT 40G BONE CEMENT, ANITBIOTIC Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 12/15/2015
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, "loosening or displacement of the prosthesis. ".

 
Event Description

Legal counsel for patient reported patient was revised approximately 5 years post-implantation due to cement loosening. This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therin are unverified. Additional information received in the patient's operative reports confirm patient was revised due to cement loosening.

 
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Brand NameCOBALT G-HV BONE CEMENT 40G
Type of DeviceBONE CEMENT, ANITBIOTIC
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6377114
MDR Text Key69092997
Report Number0001822565-2017-01489
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK051532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date02/28/2015
Device MODEL NumberN/A
Device Catalogue Number402283
Device LOT Number604410
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2014
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: 03/03/2017 Patient Sequence Number: 1
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