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

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.

• Brand Name: NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE
• Type of Device: MBH
• 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 Key: 5094733
• MDR Text Key: 26424467
• Report Number: 1822565-2015-01944
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 00596204012
• Device Lot Number: 61376517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR