MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN LPS-MOBILE ARTICULAR SURFACE

Catalog Number 00591603010

Device Problems Delamination (2904); Scratched Material (3020)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 03/11/2014

Event Type  Injury  

Event Description

It is reported that the pt was revised due to continuous pain.During the revision it was discovered that the articular surface was damaged and delaminated.Osteolysis was also reported.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN LPS-MOBILE ARTICULAR SURFACE
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46580 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 3908153
• MDR Text Key: 4488273
• Report Number: 1822565-2014-00705
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 00591603010
• Device Lot Number: 60879844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2008
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65