MAUDE Adverse Event Report: ZIMMER INC NEXGEN LPS ARTICULAR SURFACE; JWH

Model Number N/A

Device Problems Break (1069); Delamination (2904); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that revision surgery was performed due to dislocation of the articular surface.After extraction, a broken post and posterior delamination was noted.

Manufacturer Narrative

The components were reviewed for compatibility with no issues noted.No product was returned; visual and dimensional evaluations could not be performed.The device history records for the articular surface were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the articular surface.It is unknown whether the component was implanted with the correct fit and orientation as per the surgical technique.The components remained in-vivo for 15 years before the patient was revised.Per the package insert of this component, any total knee prosthesis system will not be as strong, as durable as a natural human knee joint, prosthesis fracture is a known adverse effect of this tka procedure.Therefore wear and tear from use are considered as the root cause of the issue.

• Brand Name: NEXGEN LPS ARTICULAR SURFACE
• Type of Device: JWH
• 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: 5479931
• MDR Text Key: 39945448
• Report Number: 1822565-2016-00574
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00599603214
• Device Lot Number: 66147800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2000
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention