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-32E

Device Problems Degraded (1153); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

It was noted that an unknown femoral head was also revised.It cannot be determined which, if either of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Surgeon commented that patient was experiencing pain.Decided to do a head liner exchange.

Manufacturer Narrative

An event regarding pain involving a trident liner was reported.Wear was confirmed from the material analysis.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report.Material damage consistent with damage from stem neck impingement and explantation, was observed on the distal rim of the sleeve.Wear scars were observed on the articulating surface of the insert.The distal rim of the sleeve contained damage consistent with stem neck impingement.Material analysis: wear scars were observed on the articulating surface of the insert.No material or manufacturing defects were observed on the device features examined.-medical records received and evaluation: not performed as insufficient patient medical records were provided for review.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the root cause of the reported event could not be determined based on the information received.Material analysis of the returned device confirmed there were no material or manufacturing defects.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Surgeon commented that patient was experiencing pain.Decided to do a head liner exchange.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5290922
• MDR Text Key: 33322702
• Report Number: 0002249697-2015-04204
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

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: Health Professional
• Device Expiration Date: 06/30/2008
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: U6037902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2003
• 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