MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 540-11-52E

Device Problems Degraded (1153); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Fall (1848); Pain (1994); Injury (2348); Joint Dislocation (2374)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding a wear involving a trident shell was reported.The event was confirmed following the visual inspection of an image of the explanted device.Method and results: device evaluation and results: the device was not returned, however an image of the explanted device were made available.The images showed the shell with a large circular hole present.Medical records received and evaluation: a review of the provided information by a clinical consultant noted: the principal problem of ceramic liner fracture was caused by a fall of the patient after which he experienced a pop, then subsequent grinding and pain.The correlation between event and fall as such is evident.X-rays confirm the presence of a ceramic liner fracture already before reduction of the dislocation with ceramic debris and pieces in and around the joint space.The ¿pop¿ was caused by the dislocation while the grinding was caused by the femoral head rubbing against the ceramic fracture pieces.No evidence is available to suggest that device-related factors might have played a role while the present failure scenario as based upon the reported trauma with fall of the patient as patient-related trigger event provides a more than plausible explanation for the failure event of this case.This pi case is not device-related.Device history review: all devices in the reported lot 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: a report by a clinical consultant concluded: an acute overload condition in the ceramic articulation was triggered by a patient fall causing a hip dislocation with loss of surface contact between ceramic liner and femoral head generating huge point contact forces and as such causing the ceramic fracture.If additional information and/or the device becomes available, this investigation will be reopened.Not returned.

Event Description

Scheduled revision of the right hip for (b)(6) 2016.Patient fractured right hip due to a fall.Patient experienced a pop, then subsequent grinding and pain.X-rays were taken after visit to doctor's office which shows a fractured ceramic insert.Rep will send x-rays.

• Brand Name: TRIDENT PSL HA SOLID BACK 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6184431
• MDR Text Key: 62672676
• Report Number: 0002249697-2016-03942
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2016

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: 11/30/2013
• Device Catalogue Number: 540-11-52E
• Device Lot Number: MEPX3E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2008
• 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: 51 YR