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 Problem Noise, Audible (3273)

Patient Problems Pain (1994); Weakness (2145); Discomfort (2330)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient emailed stating that had a total hip replacement in (b)(6) 2006.Over the past several months he started hearing noises, creaking, squeaking, squealing and growling noises from the area surrounding the joint.Three days ago after experiencing a rather loud growling creak, patient began to experience some discomfort in the joint.Heat/warmth pain weakness which lasted several hours.He took some pain medicine and used a heating pad which helped, but obviously have concerns.His physician has advised him to get an x-ray and see an orthopedic surgeon.

Manufacturer Narrative

Additional devices added to this report after initial submission: 6021-3535 accolade (127 deg) size 3.5 accolade (127 deg) size 3.5 15793304 6565-0-132 alumina v40-femoral head 32mm, +0mm nk 17454701 540-11-54f trident psl ha solid back 54mm 2hcmca it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no device associated with the event were returned or made available for identification or evaluation.Clinician review: the provided medical information was submitted to a consulting clinician who indicated that "the primary harm involved of noise related to a 10 plus year old ceramic on ceramic tha can not be confirmed as there is insufficient documentation presented for review." device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: it was reported that patient is experiencing creaking, squeaking, squealing and growling noises and discomfort.The event could not be confirmed nor could the root cause determined due to the minimal information received.The provided medical information was submitted to a consulting clinician who deemed the information insufficient to confirm the noise related event.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.This capa 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.Stryker orthopaedics created separate and distinct surgical techniques, one for the trident psl shell and one for the trident hemispherical shell in order to clarify the different reaming techniques recommended to achieve initial fixation.In addition, language was added to instruct users to check shell position/orientation and to assess impingement during range of motion checks.Corrective actions were fully implemented as of september 2009.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation 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.This capa 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.Stryker orthopaedics created separate and distinct surgical techniques, one for the trident psl shell and one for the trident hemispherical shell in order to clarify the different reaming techniques recommended to achieve initial fixation.In addition, language was added to instruct users to check shell position/orientation and to assess impingement during range of motion checks.Corrective actions were fully implemented as of september 2009.

Event Description

Patient emailed stating that had a total hip replacement in (b)(6) 2006.Over the past several months he started hearing noises, creaking, squeaking, squealing and growling noises from the area surrounding the joint.Three days ago after experiencing a rather loud growling creak, patient began to experience some discomfort in the joint.Heat/warmth pain weakness which lasted several hours.He took some pain medicine and used a heating pad which helped, but obviously have concerns.His physician has advised him to get an x-ray and see an orthopedic surgeon.Update as per related closed duplicate (b)(4): "i reported issues with my hip replacement device in (b)(6) to stryker.The issues were first noticed in (b)(6) 2017, and have increased in frequency and severity.I am now experiencing multiple grinding, groaning noises in the joint area, and "catching" of the joint associate with the noise.This happens a few times a day, followed by pain and discomfort for several hours.I am consulting with a surgeon at the advice of my previous surgeon.I am concerned that my device is failing rapidly and could become disjointed or dislodged completely.Medical intervention is planned for (b)(6) 2018 requiring either a revision or full replacement.Patient (self), is experiencing issues with the device implant increasing in frequency and resulting pain, discomfort and mobility.".

• 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: 7309427
• MDR Text Key: 101370193
• Report Number: 0002249697-2018-00607
• 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
• Report Date: 06/28/2018

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: 01/31/2011
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 17218002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 116