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-32F

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that surgeon converted patient's ceramic on ceramic hip to a poly liner and new head.Patient had an audible pop sound emanating from his hip whenever he would get up from a chair or take a long stride while walking - this was the reason for the head and liner exchange revision.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was confirmed.Visual inspection: a visual inspection was performed as part of the material analysis report.This visual inspection stated that: damage including metal transfer and scratching on the insert and the sleeve were likely caused during or after explantation.A wear scar was observed near the rim of the articulating surface.Material analysis: no material or manufacturing defects were observed on any of the components examined.Both the ceramic head and insert showed evidence of wear scars.A metal transfer ring near the proximal end of taper indicated proper seating of the femoral head onto the stem trunnion.Medical records received and evaluation: a review by a clinical consultant noted that: micro-separation occurs during the swing phase of the gait cycle when the foot swings in free space.By the present gravity effect of the leg ¿hanging¿ from the pelvis in the hip, only muscular contracting forces across the hip joint can counteract the centrifugal forces acting upon the hip at this point of time in the gait cycle.Such a failure mode is procedure-related because it is caused by procedural aspects of any type of arthroplasty including surgical technique and tissue removal during surgical approach to the hip while also patient-related factors relating to muscle tension and quality (atrophy) play a role.Even if impingement was the root cause of failure, this would still be a procedure-related factor because related to suboptimal component position.Device-related factors are not apparent from the information as further supported by the mar findings that excluded material or manufacturing defects on the surfaces examined.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 review of the provided information by a clinical consultant concluded that: micro-separation in the ceramic-on-ceramic bearing was quite likely present to contribute to clicking and popping sounds with the ceramic surface damage resulting as reported in the mar.If additional information becomes available this investigation will be reopened.

Event Description

It was reported that surgeon converted patient's ceramic on ceramic hip to a poly liner and new head.Patient had an audible pop sound emminating from his hip whenever he would get up from a chair or take a long stride while walking - this was the reason for the head and liner exchange revision.

Event Description

It was reported that surgeon converted patient's ceramic on ceramic hip to a poly liner and new head.Patient had an audible pop sound emminating from his hip whenever he would get up from a chair or take a long stride while walking - this was the reason for the head and liner exchange revision.

• 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 NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5454759
• MDR Text Key: 38822744
• Report Number: 0002249697-2016-00439
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 9553701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR