MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/0; IMPLANT

Catalog Number 06-2800

Device Problems Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

During surgery, a white film was noted on the head, so the scrub tech removed the device from the field and changed gloves so as not to possibly contaminate a new device or patient, etc., while the sales rep obtained a new device - same catalog number for implantation.Surgery was completed without delay.This surgery was a revision of patient's left hip - due to infection - explanted devices were not stryker products.

Manufacturer Narrative

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

Manufacturer Narrative

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.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.

Event Description

During surgery a white film was noted on the head so the scrub tech removed the device from the field and changed gloves so as not to possibly contaminate a new device or patient, etc., while the sales rep obtained a new device - same catalog number for implantation.Surgery was completed without delay.This surgery was a revision of patient's left hip - due to infection - explanted devices were not stryker products.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/0
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4908713
• MDR Text Key: 6542287
• Report Number: 0002249697-2015-02316
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 06-2800
• Device Lot Number: MLD4PY
• Other Device ID Number: STERILE LOT# MSHLE27A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2012
• 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): Other
• Patient Age: 50 YR