MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-352

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that when they opened up the exeter they noticed that the spigot protector was deformed.Another device was on hand to complete the case and there were no delays to surgery or adverse consequences for the patient.

Manufacturer Narrative

An event regarding a damaged spigot protector involving an exeter stem was reported.The event was confirmed.Method & results: device evaluation and results: on the returned spigot, it is observed that a one of the lug of the spigot is bent and the other lug is broken at the end of the lug.The missing part of this second lug was not returned.Device history review: 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 events for the reported lot.Conclusions: the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier to (b)(4).The supplier investigation concluded the defective part to have was not captured in their inspection.

Event Description

The customer reported that when they opened up the exeter they noticed that the spigot protector was deformed.Another device was on hand to complete the case and there were no delays to surgery or adverse consequences for the patient.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5461500
• MDR Text Key: 39439734
• Report Number: 0002249697-2016-00580
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2019
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5284459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• 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