MAUDE Adverse Event Report: ZIMMER INC NEXGEN ARTICULAR SURFACE PROVISIONAL; HWT

Catalog Number 00596105117

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: catalog # 00596103017, nexgen articular surface provisional, lot # 61035692; catalog # 00596105110, nexgen articular surface provisional, lot # 60987537; catalog # 00596104012, nexgen articular surface provisional, lot # 61017513; catalog # 00596102217, nexgen articular surface provisional, lot # 61023154; catalog # 00596104114, nexgen articular surface provisional, lot # 61014103; catalog # 00596103212, nexgen articular surface provisional, lot # 61035694; catalog # 00596104010, nexgen articular surface provisional, lot # 61035698; catalog # 00596103014, nexgen articular surface provisional, lot # 61035723; catalog # 00596104210, nexgen articular surface provisional, lot # 61023158; catalog # 00596105114, nexgen articular surface provisional, lot # 61007150; catalog # 00596104117, nexgen articular surface provisional, lot # 60995188; catalog # 00596103012, nexgen articular surface provisional, lot # 61035722; catalog # 00596104112, nexgen articular surface provisional, lot # 61014102; catalog # 00596104212, nexgen articular surface provisional, lot # 60987547; catalog # 00596105112, nexgen articular surface provisional, lot # 61007149; catalog # 00596102210, nexgen articular surface provisional, lot # 61027557.

Event Description

It is reported that after sterilization the articular surfaces were found to be cracked.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Visual inspection identified that the returned nexgen articular surface provisionals had cracks near the locking screw hole.These devices are used for treatment.A product history search identified no other complaints for the related part and lot combinations.The related articular surface provisionals were all manufactured in june or july 2008, giving the devices an approximate field age of 7 years and 5 months.These components have been used in an unknown number of surgeries.Per the instrument/provisional use and care package insert, end of life for reusable instruments is normally determined by wear and damage due to use.The package insert states that instruments and provisionals should be inspected prior to use and should not be used if damage or wear that may compromise the function of the instrument is noted.It appears that the noted cracks on the provisionals are due to wear and tear from use.

• Brand Name: NEXGEN ARTICULAR SURFACE PROVISIONAL
• Type of Device: HWT
• 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: 5310178
• MDR Text Key: 34352415
• Report Number: 1822565-2015-02691
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00596105117
• Device Lot Number: 61023162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2016; 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1