MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 625-0T-36G

Device Problems Degraded (1153); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.

Event Description

Revision surgery on stryker implants.Replaced with stryker stem and femoral head and depuy cup and insert (b)(6) 2020.Patient complaint of pain and squeak / chunkiness.Signs of trunionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem revision on previous primary surgery.

Event Description

Revision surgery on stryker implants.Replaced with stryker stem and femoral head and depuy cup and insert(b)(6) 2020.Patient complaint of pain and squeek / clunkiness.Signs of trunionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem revision on previous primary surgery.

Manufacturer Narrative

Reported event:  an event regarding audible noise and involving trident alumina insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photos provided show a significant amount of blood on the explanted liner with damage observed on the surface.This damage is likely due to explanation of the device.There is nothing else remarkable of note.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.Revision surgery was performed impingement evident form deformation of shell stripe wear on head op note outlined blackened tissue, indentation of femoral neck, indentation of acetabular rim, stable components.Clunk noted on exam squeaking not confirmed root cause was likely cup-stem positioning with resultant implant impingement.Inspection of implants should confirm the finding in addition to the photos.No obvious implant issues.Squeak cannot be confirmed, preoperative notes/clinic notes may confirm squeak.Squeak would be associated with reported incidence of alumina-alumina bearing.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that patient was revised due to pain and squeek / clunkiness.Signs of trunionosis and impingement noted by surgeon.Stripe wear on ceramic head.Liner rim damaged by wear from stem.The event was not confirmed.A review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.Revision surgery was performed impingement evident form deformation of shell stripe wear on head op note outlined blackened tissue, indentation of femoral neck, indentation of acetabular rim, stable components.Clunk noted on exam squeaking not confirmed.Root cause was likely cup-stem positioning with resultant implant impingement.Inspection of implants should confirm the finding in addition to the photos.No obvious implant issues.Squeak cannot be confirmed, preoperative notes/clinic notes may confirm squeak.Squeak would be associated with reported incidence of alumina-alumina bearing.The exact cause of the event could not be determined because insufficient information was provided.Additional information including progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.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.H3 other text : device not available.

• 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: 10633826
• MDR Text Key: 209955452
• Report Number: 0002249697-2020-02050
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516862
• UDI-Public: 04546540516862
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 625-0T-36G
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 32429001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 117