MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-36G

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Rash (2033); No Code Available (3191)

Event Date 04/01/2003

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Event Description

Patient has been experiencing pain, squeaking, popping, rashes, aches all over body and erectile disfunction.Left hip implanted (b)(6) 2003.

Manufacturer Narrative

A review of the provided medical records by a medical consultant noted that there was no confirmation of the complaints noted in the event description and no x-ray evidence of pathology as of (b)(6) 2015.There is no evidence of faulty component design, manufacturing or materials being responsible for these event descriptions.A review of the device history records indicated that all the devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.The complaint history review revealed one other event for the subject lot.

Event Description

Patient has been experiencing pain, squeaking, popping, rashes, aches all over body and erectile disfunction.Left hip implanted 06-23-2003.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill 00000 ; EI 00000
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5001610
• MDR Text Key: 22903126
• Report Number: 0002249697-2015-02617
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2008
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: U5269701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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