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

Catalog Number 6260-9-236

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Chemical Exposure (2570); Test Result (2695)

Event Date 05/27/2015

Event Type  Injury  

Event Description

Patient's right hip was revised due to high metal ions and pain - hipstar stem.Surgeon performed an osteotomy around implants to remove - surgeon noted a lot of gray matter built up around trunnion of neck and head, surgeon also noted several times that the bone removed from around explants was noted to be rubbery and soft.

Manufacturer Narrative

It was noted that no additional records will be provided by hospital.Therefore, 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 reported discrepancies.Complaint history review indicated that there have been no other events for the reported lot.Patient retained device.

• 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: 4860478
• MDR Text Key: 5851025
• Report Number: 0002249697-2015-02017
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2015

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: 09/30/2013
• Device Catalogue Number: 6260-9-236
• Device Lot Number: EL1MME
• Other Device ID Number: STER. LOT MSHEN05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2008
• 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: 73