MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/+5; IMPLANT

Catalog Number 06-3205

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Alteration In Body Temperature (2682)

Event Date 06/09/2014

Event Type  Injury  

Event Description

Patient has a painful left total hip replacement, all component positioning appears correct radiographically.Patient brought to the or for exploration with possible component replacement.Upon removal of the femoral head, it was noted that the trunion and inner surface of the head were covered by gray sludge.It was decided to replace the head and liner to a universal biolox head with mdm liner and head.The hip was stable and the pt was irrigated with 3 liters of irrigation and closed.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Visual, dimensional and functional analysis could not be performed as the device was not returned.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 no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient has a painful left total hip replacement, all component positioning appears correct radiographically.Patient brought to the operating room for exploration with possible component replacement.Upon removal of the femoral head, it was noted that the trunion and inner surface of the head were covered by gray sludge.It was decided to replace the head and liner to a universal biolox head with mdm liner and head.The hip was stable and the pt was irrigated with 3 liters of irrigation and closed.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/+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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3910574
• MDR Text Key: 4586998
• Report Number: 0002249697-2014-02509
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2012
• Device Catalogue Number: 06-3205
• Device Lot Number: 0REMED
• Other Device ID Number: STERILE LOT# MSH0703G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2007
• 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: 64 YR
• Patient Weight: 60