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

Catalog Number 625-0T-32F

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 10/08/2014

Event Type  Injury  

Event Description

Trident psl cup with ceramic liner revised.The liner does not appear fully seated.This construct was articulating with a depuy srom stem with a biolox head.Patient experiencing right hip pain.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Hospital policy.

Manufacturer Narrative

The patient is (b)(6) inches in height.An event regarding seating/locking issues involving a trident liner was reported.The event was confirmed.Medical records received and evaluation: a medical review was performed and concluded: "two relevant procedure-related factors present in this case are overhanging osteophytes that were not removed at implantation surgery while it is also possible that the screws as used for augmentation of cup fixation have interfered with proper liner seating through a protruding screw head.This pi case is not device-related." conclusions: a medical review was performed and indicated that there was no evidence of a device related issue.The exact root cause of the event however could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, and return of the device are needed to fully investigate the event.

Event Description

Trident psl cup with ceramic liner revised.The liner does not appear fully seated.This construct was articulating with a depuy srom stem with a biolox head.Patient experiencing right hip pain.

• 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; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4221667
• MDR Text Key: 5077178
• Report Number: 0002249697-2014-04118
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 93