MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-336

Device Problems Metal Shedding Debris (1804); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414); Test Result (2695)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Event Description

Right total hip revision for elevated smetal ion and cobaltism.Insert and head revised.

Manufacturer Narrative

An event regarding ¿elevated metal ions and cobaltism¿ involving a metal head was reported.The event was not confirmed.Visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.A review of the provided medical records and x-rays by a clinical consultant indicated: ¿based upon the information available for review, there is no confirmation of the analysis of the surgeon implicating the head/neck corrosion as the cause of this clinical situation.¿ review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.The event could not be confirmed nor the root cause determined based on the clinician¿s report that ¿based upon the available clinical information for review, there is no confirmation of the analysis of the surgeon implicating the head/neck corrosion as the cause of this clinical situation.¿ the device was not returned or identified in this complaint.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Right total hip revision for elevated metal ions and cobaltism.Insert and head revised.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6331997
• MDR Text Key: 67478673
• Report Number: 0002249697-2017-00577
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 6260-9-336
• Device Lot Number: 223MEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 106