MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #6 RIGHT; IMPLANT

Catalog Number 6265-5116

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

It was reported that upon inspection sales rep found out that packaging of implants was compromised.Surgeon used the implants.Only the out packaging is being return to us.Surgery was completed without any complications.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Packaging will be returned.

Manufacturer Narrative

An event regarding a compromised seal involving a citation tmzf ha stem #6 right was reported.The event was confirmed.Device evaluation and results: visual inspection of the returned packaging indicated that the inner seal was compromised and that the outer box had some damage on the edges.A memo from packaging engineers indicated that there was not an issue with the manufacturing of the device packaging.Dimensional and functional evaluations were not performed as the reported event was not related to the dimensions or functionality of the device.-device history review: indicated that the specified lot was accepted into final stock with no reported discrepancies.-complaint history review: indicated that there have not been any other events for the specified lot.Conclusions: the reported event involves compromised packaging for a citation stem.The implant was used and the packaging was returned for evaluation.The root cause of the event cannot be confirmed but it is likely that the inner seal separated due to the inner plastic package rubbing against the outer plastic package during shipment.This scenario is indicated by the sales rep as the cause of failure.

Event Description

It was reported that upon inspection sales rep found out that packaging of implants was compromised.Surgeon used the implants.Only the out packaging is being return to us.Surgery was completed without any complications.

• Brand Name: CITATION TMZF HA STEM #6 RIGHT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4018036
• MDR Text Key: 17991714
• Report Number: 0002249697-2014-03169
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 6265-5116
• Device Lot Number: 42053101
• Other Device ID Number: STER. LOT 1302ACM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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): Other