MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; IMPLANT

Catalog Number 6260-9-236

Device Problems Metal Shedding Debris (1804); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was revised for hip pain.On (b)(6) 2015, it was indicated that there was a lot of metal particles in the joint fluid and surrounding tissues and obvious deformation of the trunion of the stem.

Manufacturer Narrative

The reported event was confirmed.Visual inspection and material analysis of the returned devices concluded that the distal and taper surfaces of the head exhibited material damage and wear consistent with damage resulting from movement against the stem trunnion.No material or manufacturing defects were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

It was reported that the patient was revised for hip pain.On (b)(6) 2015, it was indicated that there was a lot of metal particles in the joint fluid and surrounding tissues and obvious deformation of the trunnion of the stem.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5038614
• MDR Text Key: 24400613
• Report Number: 0002249697-2015-02837
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Followup
• Report Date: 08/03/2015

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: 09/30/2011
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 25VMNA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2006
• 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: 51 YR
• Patient Weight: 105