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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH

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ZIMMER INC NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE MBH Back to Search Results
Catalog Number 00596204012
Device Problems Failure To Adhere Or Bond (1031); Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/19/2015
Event Type  Injury  
Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a. (b)(4). This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient was revised due to loosening in his knee. Upon revision, it was discovered that the post of the articular surface was broken and missing. Pieces of the post were retrieved from the joint and soft tissue, however not all pieces were found.

 
Manufacturer Narrative

Visual inspection confirmed that the spine of the poly has been fractured off. The dovetail feature appears to be flared out as a result of removal of the implant and the backside notch is gouged. The articular surface shows discoloration and pitting. There are scratches and gouges all over the device. Dimensions were found conforming to print specifications where measured. Review of the device history records did not find any deviations or anomalies. A product history search revealed no additional complaints against the related part and lot combination. Compatibility was reviewed with no issued noted. This device is used for treatment. Nexgen cr-flex and lps-flex fixed bearing knee package insert states that "loosening or fracture/damage of the prosthetic knee components or surrounding tissues" is a possible adverse effect. This is therefore a known inherent risk of the procedure. A definitive root cause cannot be determined with the information provided.

 
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Brand NameNEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE
Type of DeviceMBH
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5094733
MDR Text Key26424467
Report Number1822565-2015-01944
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 08/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2014
Device Catalogue Number00596204012
Device LOT Number61376517
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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