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-32E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

The following device was also listed in this report: ceramic femoral head; cat# unknown; lot# unknown it cannot be determined, if any of this device may have caused or contributed to the patient's experience.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.Device not available.

Event Description

It was reported that the patient's right hip was revised due to infection.A head and insert swap (ceramic on ceramic bearing) with washout was performed.Patient was revised to a 36 +5 lfit v40 femoral head and poly liner.Rep cannot obtain any additional information as the surgery took place at an unknown hospital with an unknown surgeon.

Manufacturer Narrative

Corrected data: d2a/d2b.An event regarding infection involving a trident liner was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, 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: no examination of explanted components and no narrative operative report of the primary right total hip arthroplasty on (b)(6) 2013 are available.The early periprosthetic infection requiring surgery one month post implantation may have been related to the skin lesion and recent lipoma surgery to the right thigh in this obese patient, as noted in the records.Based upon the information available for review, no determination can be made regarding the loss of interface locking and disassociation of the head/trunnion junction occurring six-and-a-half years post-implantation.The early revision of the ceramic head to a metal replacement without an intervening sleeve may have resulted in damage to the retained trunnion resulting in accelerated crevice corrosion and erosion/disassociation.-product history review: review of the device history records indicate 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.There has been no other similar event for the sterile lot referenced.Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices information was listed in this report after the initial mdr was filed: cat# 6565-0-132; alumina v40-femoral head 32mm, +0mm nk; lot# 42193602.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

It was reported that the patient's right hip was revised due to infection.A head and insert swap (ceramic on ceramic bearing) with washout was performed.Patient was revised to a 36 +5 lfit v40 femoral head and poly liner.Rep cannot obtain any additional information as the surgery took place at an unknown hospital with an unknown surgeon.

• 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: 8991025
• MDR Text Key: 161579769
• Report Number: 0002249697-2019-03175
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 42578102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 120