MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-373

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 01/19/2016

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 stem the spigot protector was deformed.Another device was on hand to complete the case and there were no adverse consequences or delays to surgery.

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: the 2 lugs of the spigot are bent: one lug is slightly bent whereas the second lug is more bent.They are marks of use of the instrument on the body of the spigot, under the bent lugs.White dust is present on the top of the stem and inside the spigot.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 (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 stem the spigot protector was deformed.Another device was on hand to complete the case and there were no adverse consequences or delays to surgery.

• Brand Name: EXETER V40 STEM 37.5MM NO 3
• 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: 5454748
• MDR Text Key: 39236944
• Report Number: 0002249697-2016-00465
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: 0580-1-373
• Device Lot Number: G5529672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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