MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-52E
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional 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 other 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.
Event or Problem Description
It was reported by the sales rep that acetabulum shell migrated superiorly over the years.Dr.Did navigation assisted thr revision with putting bone graft in acetabulum, changed the shell, insert and femoral head.Stem remained.
Additional Manufacturer Narrative
Reported event; an event regarding malposition and loosening involving a trident 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 was not returned.Clinician review: a review of medical records with a clinical consultant indicated i can confirm that the patient had a left total hip arthroplasty since i was able to see where graphs with the implant in place although only the revision construct was noted to be ¿l¿.No date is present on either radiographic document.I do not have any operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cementless acetabular component are multi factorial including surgical technique, especially in the fixation and positioning of the cup, and the initial stability of the cup as well as the patient host bone.Patient factors such as host bone quality, lifestyle, activity level, and bmi can contribute.With the information provided, i would not assign any causality to the implant itself.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.Conclusions: a review of medical records with a clinical consultant indicated i can confirm that the patient had a left total hip arthroplasty since i was able to see where graphs with the implant in place although only the revision construct was noted to be ¿l¿.No date is present on either radiographic document.I do not have any operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of loosening of a cementless acetabular component are multi factorial including surgical technique, especially in the fixation and positioning of the cup, and the initial stability of the cup as well as the patient host bone.Patient factors such as host bone quality, lifestyle, activity level, and bmi can contribute.With the information provided, i would not assign any causality to the implant itself.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Additional info.22-may-2025: 1.Left hip revision.2.Low activity level.Normal daily walking in household.3.Surgeon refused to disclose operative reports for p&c reason.But mentioned that patient is recovering ok.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 52MM
• Common Device Name: 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21383526
• Report Number: 0002249697-2025-00202
• Device Sequence Number: 8525918
• Product Code: LPH
• UDI-Device Identifier: 07613327037197
• UDI-Public: 07613327037197
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 542-11-52E
• Device Lot Number: 71118403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown