MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM -4 V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-032

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/29/2014

Event Type  Injury  

Event Description

During revision surgery it was noticed that the trunnions and the head presented a black substance.The cup was revised and the head was exchanged with a new head and sleeve.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding a black substance involving a 32mm -4 v40 taper vit head was reported.The event was confirmed.A visual inspection noted a black substance on the female taper.Insufficient medical records were provided for review.Device history review.A device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review.A complaint history review confirmed no other similar events for the reported lot.The exact cause of the event could not be determined because of a lack of information.Further information such as the reported device, operative reports, and medical records are needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time.

Event Description

During revision surgery it was noticed that the trunnions and the head presented a black substance.The cup was revised and the head was exchanged with a new head and sleeve.

• Brand Name: 32MM -4 V40 TAPER VIT HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3643453
• MDR Text Key: 19920102
• Report Number: 0002249697-2014-00509
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: 6260-5-032
• Device Lot Number: 18239101
• Other Device ID Number: STERILE LOT# 0604GC4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2006
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 57