MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 702-04-56F

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name: high insignia collared hip stem; cat#7000-6605 ; lot#10979953.Device name: delta v-40 ceramic head 36/-2,5; cat#6570-0-436 ; lot#10823454.Device name: tridentii tritanium cluster56f; cat#702-04-56f ; lot#11888651a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned.

Event Description

As reported: "patient reported to clinic with a left hip periprosthetic joint infection and underwent revision surgery." all implants were removed.

Manufacturer Narrative

The following devices were also listed in this report: cat# 7000-6605; high insignia collared hip stem; lot# 10979953.Cat# 6570-0-436; delta v-40 ceramic head 36/-2,5; lot# 10823454.Cat# 723-00-36f; trident 0 deg x3 insert 36f; lot# 2470ma.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a trident ii shell was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: a primary exchange revision was performed for presumed infection.Cemented implants with antibiotic cement were placed.No organism, preoperative, postoperative, radiographs or other information defining the history, or the pathology were provided for evaluation.Event confirmation: a revision surgery was performed for presumed infection.This can be confirmed.The infection itself cannot be confirmed without additional information." 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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.Intraoperatively, loosening of the acetabular component was also observed.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays, 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.

Event Description

As reported: "patient reported to clinic with a left hip periprosthetic joint infection and underwent revision surgery." all implants were removed.Update: revision op report indicated that the acetabular component was observed to be loose upon removal.

• Brand Name: TRIDENTII TRITANIUM CLUSTER56F
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18299618
• MDR Text Key: 330111057
• Report Number: 0002249697-2023-01524
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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 Catalogue Number: 702-04-56F
• Device Lot Number: 11888651A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 93 KG