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

Catalog Number 625-0T-32E

Device Problems Mechanical Problem (1384); Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported that the hip was revised because the patient fell and then complained about a mechanical grinding.The femoral head and ceramic liner were exchanged.

Manufacturer Narrative

The event was confirmed based upon images of the explanted device which show a chip fracture of the rim of the alumina ceramic bearing.A review of the provided medical records by a clinical consultant concluded that a traumatic fracture of ceramic liner occured after the patient fall causing a rim chip fracture interfering with normal joint kinematics and thereby generating a grinding sound.Patient-related failure mode due to fall without procedure-related or device-related aspects.In conclusion, the clinical consultant indicated that ''trauma of fall is principal cause of ceramic fracture and thus revision surgery and thereby principal cause of failure''.

Manufacturer Narrative

An event regarding crack/fracture of a trident liner was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.Images were provided and the explant shows a chip fracture of the rim of the alumina ceramic bearing.Medical records received and evaluation: a review of the provided information by a clinical consultant concluded: traumatic fracture of ceramic liner after a patient fall causing a rim chip fracture interfering with normal joint kinematics and thereby generating a grinding sound.Patient-related failure mode due to fall without procedure-related or device-related aspects.Device history review could not be performed as the lot id is unknown complaint history review could not be performed as the lot id is unknown.Conclusions: a review of the event by a clinical consultant indicated that ''trauma of fall is principal cause of ceramic fracture and thus revision surgery and thereby principal cause of failure''.No further investigation is possible at this time.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that the hip was revised because the patient fell and then complained about a mechanical grinding.The femoral head and ceramic liner were exchanged.

• 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: 4808596
• MDR Text Key: 17546152
• Report Number: 0002249697-2015-01747
• 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: 05/05/2015

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 Catalogue Number: 625-0T-32E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 06/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 54