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

Catalog Number 625-0T-32E

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 04/03/2015

Event Type  Injury  

Event Description

It was reported that there was a revision of suspected failed ceramic on ceramic total hip 04/08/2015: the sales rep confirmed that the surgeon originally thought the head was broken.However, during the revision, the surgeon discovered the head was completely intact but the ceramic liner was broken in several pieces.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

An event regarding crack/fracture involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results:not performed as the reported device was not returned for evaluation.A surgical image of the device was provided.The liner fractured into multiple fragments medical records received and evaluation: a medical review was performed and concluded: "x-rays confirm the presence of a ceramic fracture with the trident cup in a very steep inclination position of 64°.The root cause of this pi failure case is procedure-related regarding cup malposition through excessive inclination thereby causing peak contact forces in the articulation with overload and shear point contact forces in the bearing easily contributing to ceramic fracture, in this case of the liner.This pi case is not device-related" device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: a medical review was performed and concluded that this event is not device related and the root cause of failure is associated with cup malposition.Additional information, including operative reports, progress notes and return of the device are however needed to perform a full review.

Event Description

It was reported that there was a revision of suspected failed ceramic on ceramic total hip on 04/08/2015: the sales rep confirmed that the surgeon originally thought the head was broken.However, during the revision, the surgeon discovered the head was completely intact but the ceramic liner was broken in several pieces.

• 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: 4730958
• MDR Text Key: 16853389
• Report Number: 0002249697-2015-01386
• 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: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 10362602
• Other Device ID Number: STER. LOT 0408PIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2004
• 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
• Patient Age: 62 YR
• Patient Weight: 54