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-36G

Device Problem Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 12/11/2006

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient called stating he had a right hip replacement on (b)(6) 2006.6 months after his surgery he noticed a loud noise every time he took a step.Patient wants to know if his implant is part of a recall.

Manufacturer Narrative

An event regarding audible noise involving an unknown ceramic liner was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as no product was performed.Clinician review: a review of the primary and revision operative reports and office notes by the consulting clinician revealed "review of these records confirms squeaking in a tha occurred.However, the root cause cannot be determined.The squeaking began following ipsilateral knee replacement and likely is in some way related to changing weight bearing stresses within the hip articulation.To date the hip has not been revised so material analysis has not been carried out on the implants involved.The only knee x-rays available for review were dated (b)(6) 2006 and these images showed knees in neutral alignment with only mild degenerative changes.It would be helpful to be able to review recent pre-operative and post-operative knee films to see how much if any angular correction was effected at the knee.Orthopedic clinic notes pre and postoperatively documenting range of motion of the knee and hip would also be useful in helping to understand the potential cause of this acoustic phenomena." conclusions: it was reported that the patient noticed a loud noise every time he took a step.The reported event was confirmed.A review of the available medical records by the consulting clinician indicated "review of these records confirms squeaking in a tha occurred.However, the root cause cannot be determined.The squeaking began following ipsilateral knee replacement and likely is in some way related to changing weight bearing stresses within the hip articulation.To date the hip has not been revised so material analysis has not been carried out on the implants involved." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Although the lot code was not provided, the device description and the date of implant and hazard/harm combination, suggests that the device is in scope of the capa.An analysis of the overall complaint data, and additional information concerning this evaluation is documented in the capa.In the capa, stryker orthopaedics determined that the root cause of squeaking is associated with repetitive edge loading of the femoral bearing against the edge of the ceramic insert.Edge loading, the mechanism by which a wear scar (stripe wear) is generated on the ceramic bearing surfaces, is primarily associated with impingement, joint laxity, and implant orientation.Based on laboratory testing, the conditions required to produce an audible noise are multi-factoral and include the right combinations of load, contact stress, load transition, and lubrication conditions with the presence of stripe wear being a critical factor.

Event Description

Patient called stating he had a right hip replacement on (b)(6) 2006.6 months after his surgery he noticed a loud noise every time he took a step.Patient wants to know if his implant is part of a recall.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was confirmed by medical review.Method & results: - device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 28-january-2020 which indicated, the parts were examined with the aid of a stereo microscope at magnifications up to 200x.Damage was observed on the titanium sleeve of the trident alumina insert, consistent with the explantation process.A detailed image of the articulating surface of the ceramic insert is shown with damage being observed.This damage is consistent with in-service use.A material analysis has been performed.The report concluded that damage was observed on the titanium sleeve of the trident alumina insert, consistent with the explantation process.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.- clinician review: a review of the provided medical records and/or x-rays by a clinical consultant concluded," review of these records confirms squeaking in a ceramic on ceramic tha occurred.Squeaking is a well-recognized complication for hard-on-hard bearings.The nature of squeaking is not yet completely understood however it is considered a multifactorial phenomenon.Patient, implant, and surgical factors play a role in squeaking.It is unclear which of these factors played a role in this instance.The squeaking was present intermittently shortly after implantation but became much more prevalent following ipsilateral knee replacement and likely is in some way related to changing weight bearing stresses within the hip articulation." - device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.- complaint history review: there have been no other event for the lot referenced.Conclusions: it was reported that the patient noticed a loud noise every time he took a step.A material analysis has been performed.The report concluded that damage was observed on the titanium sleeve of the trident alumina insert, consistent with the explantation process.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records and/or x-rays by a clinical consultant concluded that review of these records confirms squeaking in a ceramic on ceramic tha occurred.Squeaking is a well-recognized complication for hard-on-hard bearings.The nature of squeaking is not yet completely understood however it is considered a multifactorial phenomenon.Patient, implant, and surgical factors play a role in squeaking.It is unclear which of these factors played a role in this instance.The squeaking was present intermittently shortly after implantation but became much more prevalent following ipsilateral knee replacement and likely is in some way related to changing weight bearing stresses within the hip articulation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: per corrective action/preventive action policy and procedures stryker orthopaedics conducted an investigation to evaluate reports of audible noise during motion involving trident ceramic bearing systems.An analysis of the overall complaint data, and additional information concerning this evaluation is documented in capa.In capa stryker orthopaedics determined that the root cause of squeaking is associated with repetitive edge loading of the femoral bearing against the edge of the ceramic insert.Edge loading, the mechanism by which a wear scar (stripe wear) is generated on the ceramic bearing surfaces, is primarily associated with impingement, joint laxity, and implant orientation.Based on laboratory testing the combinations required to produce an audible noise are multi-factoral and include the right combination of load, contact stress, load transition and lubrication conditions with the presence of stripe wear being a critical factor.

Event Description

Patient called stating he had a right hip replacement on (b)(6) 2006.6 months after his surgery he noticed a loud noise every time he took a step.Patient wants to know if his implant is part of a recall.Update-the patient had a 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
• MDR Report Key: 7968842
• MDR Text Key: 123816605
• Report Number: 0002249697-2018-03359
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 20818601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 120