MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-136

Device Problems Corroded (1131); Degraded (1153); Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to corrosion involving a v40 cocr lfit head 36mm/0 was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis has been performed.The report concluded: damage and debris were observed on the taper of the head.Eds on the head was consistent with a cocr alloy.Eds on the debris was consistent with a corrosion product, material transfer from the hip stem and biological material.No materials or manufacturing defects were observed on the surfaces examined.Device history review: all devices in the reported lot were manufactured and accepted into final sock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact root cause could not be determined because no medical information was provided.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Procedure was completed successfully.Replaced items were the polyethylene insert and femoral head.Dr.(b)(6) also added a cancellous bone screw to the shell for stability and a taper adapter sleeve to address any concerns with micro motion.

• Brand Name: V40 COCR LFIT HEAD 36MM/0
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5371651
• MDR Text Key: 36197002
• Report Number: 0002249697-2016-00114
• 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
• Report Date: 10/23/2015

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: 07/30/2017
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MLKL1J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2012
• 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): Required Intervention
• Patient Age: 78 YR