MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; IMPLANT

Catalog Number 0580-1-352

Device Problems Failure to Align (2522); Mechanics Altered (2984)

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

Event Date 06/09/2014

Event Type  malfunction  

Event Description

The customer reported via the sales business manager that during a procedure three spigot protectors were found to have moulding faults.The customer reported that one of the 'prongs' was found to be out of alignment on all three devices.The customer reported that one device was discarded but two were kept for investigation.The customer reported that the procedure was completed successfully with less than a few minutes delay to surgery time as a replacement device was immediately available.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturing date and expiration date corrected.An event regarding damaged spigots involving an exeter stem was reported.The event was not confirmed.Device evaluation and results.The devices were not returned for evaluation.Photographs were provided and reviewed.There is evidence to indicate that the lug of the spigot is damaged.Medical evaluation not performed as medical records were not received for evaluation.Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review.A review of the complaint history database shows that there have been no similar reported events for the subject lot code.The exact cause of this event could not be determined based on the information available.

Event Description

The customer reported via the sales business manager that during a procedure three spigot protectors were found to have moulding faults.The customer reported that one of the 'prongs' was found to be out of alignment on all three devices.The customer reported that one device was discarded but two were kept for investigation.The customer reported that the procedure was completed successfully with less than a few minutes delay to surgery time as a replacement device was immediately available.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: 3923044
• MDR Text Key: 4517246
• Report Number: 0002249697-2014-02576
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K011623
• 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: 06/11/2014

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: 10/31/2018
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G3907853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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