MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; IMPLANT

Catalog Number 6260-9-240

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported by the patient's son-in-law that the patient had primary surgery in 2010 at (b)(6).The patient had revision of her accolade stem in late (b)(6) 2015 by the same surgeon.It is alleged that the patient had a pseudotumor, metallosis and other medical conditions which, per the son-in-law surgeon is relating to alleged metallosis.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown femoral head.It was noted that the patient is being represented by legal counsel.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Review of device history records indicates the lot was manufactured and accepted into final stock on 21-jul-2010.There have been no other events for the lot referenced.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported by the patient's son-in-law that the patient had primary surgery in 2010 at emory university in atlanta.The patient had revision of her accolade stem in late (b)(6) 2015 by the same surgeon.It is alleged that the patient had a pseudotumor, metallosis and other medical conditions which, per the son-in-law surgeon is relating to alleged metallosis.

• Brand Name: V40 COCR LFIT HEAD 40MM/+4
• Type of Device: IMPLANT
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4621253
• MDR Text Key: 5761415
• Report Number: 0002249697-2015-00822
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2015

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: 07/30/2015
• Device Catalogue Number: 6260-9-240
• Device Lot Number: MJKNK3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• 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: 80 YR