MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32F

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2013

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 reported he has a right stryker ceramic on ceramic hip.The patient started experiencing pain and audible popping in right hip in 2013.Patient stated that a mri revealed patient has a gluteus medius muscle that is not connected to bone.

Manufacturer Narrative

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.The device history review indicated all devices were manufactured and accepted into final stock with no relevant discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

Patient reported he has a right stryker ceramic on ceramic hip.The patient started experiencing pain and audible popping in right hip in 2013.Patient stated that a mri revealed patient has a gluteus medius muscle that is not connected to bone.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5031358
• MDR Text Key: 24086049
• Report Number: 0002249697-2015-02779
• 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
• Type of Report: Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 12002602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2005
• 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: 68 YR