MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; IMPLANT

Catalog Number 0580-1-441

Device Problems Sticking (1597); Device Packaging Compromised (2916)

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

Event Date 03/12/2014

Event Type  malfunction  

Event Description

It was reported that the top layer packaging stuck to sterile packaging upon opening.A replacement was opened and it was ok.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding packaging seal involving an exeter stem was reported.The event was confirmed.The device and all of the packaging except for the shrink wrap was returned.The returned device has the external tyvek partially removed showing a compliant seal flange.The inner tyvek is delaminated.Medical evaluation not performed as not required.The device was not used in surgery.A device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.A review of the complaint history database shows that there has been no other similar reported events for the subject lot code.The investigation concluded that the inner tyvek is delaminated when the outer tyvek is opened because the inner tyvek is stuck on the outer seal flange at the bottom right corner of the blister.The tolerance on the inner tyvek and the inner blister allows to 1-2 mm out of the corner seal flange.

Event Description

It was reported that the top layer packaging stuck to sterile packaging upon opening.A replacement was opened and it was ok.

• Brand Name: EXETER V40 STEM 44MM NO 1
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3735721
• MDR Text Key: 16448918
• Report Number: 0002249697-2014-01067
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K011623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G3931480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2013
• 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