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 Break (1069); Fracture (1260); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Date 04/09/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.This device is not cleared for sale in the united states but a similar device is commercially available for sale in the united states.

Event Description

It was reported that the patient had a revision for fractured ceramic on ceramic liner and head.

Manufacturer Narrative

An event regarding crack/fracture involving a ceramic liner was reported.Conclusion based on the information provided there is no indication that the product reported in this investigation contributed to the event.There was no allegation of failure for the head.The medical review concluded that cup malposition in high anteversion and inclination contributed to edge loading and/or subluxation in the ceramic bearing causing point contact with extreme overload in the ceramic bearing resulting in a ceramic liner fracture.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient had a revision for fractured ceramic on ceramic liner and head.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a trident liner was reported.The event was confirmed for liner fracture and for cup malposition from the medical review.Method & results: device evaluation and results: damage and wear scars were observed on the articulating surface on the insert.No materials or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the medical records by a clinical consultant noted: x-rays confirm a vertical and anteverted cup shell with eccentricity of the femoral head and ceramic debris in the joint space indicating the liner had fractured.Anteversion malposition was approximately 25°.This was confirmed at revision surgery where also the surgeon confirmed the cup was vertical and anteverted with rim loading as result.Diagnosis: - cup malposition in high anteversion and inclination contributed to edge loading and/or subluxation in the ceramic bearing causing point contact with extreme overload in the ceramic bearing resulting in a ceramic liner fracture.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been one other event for the reported lot for a previous event for the same patient.Conclusions: a review by a clinical consultant concluded that the cause of the event was: cup malposition in high anteversion and inclination contributed to edge loading and/or subluxation in the ceramic bearing causing point contact with extreme overload in the ceramic bearing resulting in a ceramic liner fracture.No further investigation for this event is possible at this time.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

It was reported that the patient had a revision for fractured ceramic on ceramic liner and head.

• 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 00000
• Manufacturer Contact: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5153290
• MDR Text Key: 28400956
• Report Number: 0002249697-2015-03402
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2007
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 3889903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2002
• 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; Other; Required Intervention