MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 48MM; IMPLANT

Catalog Number 542-11-48D

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 07/26/2014

Event Type  Injury  

Event Description

Patient presented in the emergency department at the (b)(6) with a painful right hip.She was 2 years post tha for fx.Radiographs showed a protruded acetabular component.The patient was brought to the operating room the next day.A 54mm tritanium revision shell was placed with multiple screws and a 36mm x3 liner.

Event Description

Patient presented in the emergency department at the (b)(6) hospital with a painful right hip.She was 2 years post tha for fx.Radiographs showed a protruded acetabular component.The patient was brought to the operating room the next day.A 54mm tritanium revision shell was placed with multiple screws and a 36mm x 3 liner.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information (including x-rays and medical records) 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 protruded acetabular component involving a trident psl ha cluster 48mm was reported.The event was not confirmed.Device evaluation not performed as no items were received.Medical evaluation not performed as no medical records were received.Device history review.Indicated all devices accepted into final stock met specifications.Complaint history review indicated there have been no other events for the lot referenced.The exact cause of the event could not be determined because no devices and/or medical records were received.No further investigation for this event is possible at this time.

• Brand Name: TRIDENT PSL HA CLUSTER 48MM
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4018314
• MDR Text Key: 4849394
• Report Number: 0002249697-2014-03149
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983382
• 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: 07/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 542-11-48D
• Device Lot Number: MLADX5
• Other Device ID Number: STERILE LOT# MSHLA31A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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: 90 YR