MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BK 52MM; IMPLANT

Catalog Number 500-01-52E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 11/26/2007

Event Type  Injury  

Event Description

It was reported by the attorney for the patient as a result of a lawsuit that allegedly the patient underwent right hip surgery using trident acetabular hip system on (b)(6), 2007.It is alleged the patient began to experience extreme pain and elevated metal levels.The patient was revised on (b)(6), 2012.

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs.No additional devices have been reported at this time.Due to ongoing litigation, no requests will be made for additional information.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available - legal.

Manufacturer Narrative

An event regarding pain and elevated metal levels involving a trident hemispherical solid bk 52mm was reported.The event was not confirmed.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.Conclusions: the exact cause of the event could not be determined because of a lack of information.Further information such as the reported device, medical records, and x-rays are needed to complete the investigation for determining the root cause.

Event Description

It was reported by the attorney for the patient as a result of a lawsuit that allegedly the patient underwent right hip surgery using trident acetabular hip system on (b)(6) 2007.It is alleged the patient began to experience extreme pain and elevated metal levels.The patient was revised on (b)(6) 2012.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BK 52MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3875327
• MDR Text Key: 4566081
• Report Number: 0002249697-2014-02310
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Catalogue Number: 500-01-52E
• Device Lot Number: 20961801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2006
• 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): Hospitalization; Required Intervention