MAUDE Adverse Event Report: ZIMMER, INC. CONTINUUM TRABECULAR METAL SHELL WITH CLUSTER HOLES; LZO

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the cup would not disconnect from the inserter.

Manufacturer Narrative

(b)(4).The hybrid offset shell inserter with shell impaction adaptor and tm cluster hole shell were returned for review.The pieces were assembled when received, and disassembled for inspection.Visual inspection reveals that the inserter shows signs of wear and tear, suggesting extensive use.The frequency of use of this instrument is unknown.The inserter hex bolt is fractured at the head and shaft junction.The bolt was retained and constrained by the inserter tip, keeping the shell from being disengaged.The threading still accepts a (b)(4) thread ring gauge.Shell threads were damaged during disassembly.The shell threads will not accept a (b)(4) thread plug gauge.The shell inserter's potential field age is approximately 4 years and 4 months based on manufacturing date.Dimensional analysis was found to be conforming.Device history reports were reviewed and showed no deviations or anomalies in the manufacturing process of any of these devices.These devices are used for treatment.No previous complaints were found for the shell part and lot combination reported.Previous investigation captures the failure mode of bolt fracture specific to hybrid offset shell inserter.The failure occurs due to a reduced cross-sectional thickness at the root of the bolt.This is caused by the drill point that is used in the hex manufacturing.A material change (mc) was implemented to increase the hex bolt head height, eliminate the drill point, and increase the shank fillet radius, thus reducing stress in the failure region.Because this device precedes that design change, the likely cause for the reported issue is a previously addressed design issue.

• Brand Name: CONTINUUM TRABECULAR METAL SHELL WITH CLUSTER HOLES
• Type of Device: LZO
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5663876
• MDR Text Key: 45418215
• Report Number: 0001822565-2016-01623
• Device Sequence Number: 1
• Product Code: LZO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875705401
• Device Lot Number: 63257043
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1