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 Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The stem neck on both sides have been shaved off.Future treatment plan is currently under consideration.Left hip.Patient had pain and restriction of activities.Per medical review: ".Given the position of the acetabular components this may well be due to impingement of the femoral neck on the acetabular component.".
Additional Manufacturer Narrative
An event regarding rom involving a trident shell was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a total hip arthroplasty with bilateral cementless implants and approximately three years later was found to have notches in both femoral prosthetic necks.I am able to confirm that this event occurred since i was able to review x-rays with the notches present.The root cause of this event cannot be determined with certainty.The causes of notching are multifactorial.However given the position of the acetabular components this may well be due to impingement of the femoral neck on the acetabular component.The possibility of abnormal position of the femoral component is less likely.Also possibly contributing to this phenomena would be the patient's activity level with lifestyle choices such as extreme positions in yoga, etc.Having said that, in my experience, with well positioned implants this notching does not occur.The patient should have at the very least, true cross table lateral views to determine the anteversion of the acetabular component and a ct scan to determine both the anteversion of the acetabular component and the femoral component." 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: it was reported that the stem neck had been "shaved off." a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a patient who underwent a total hip arthroplasty with bilateral cementless implants and approximately three years later was found to have notches in both femoral prosthetic necks.I am able to confirm that this event occurred since i was able to review x-rays with the notches present.The root cause of this event cannot be determined with certainty.The causes of notching are multifactorial.However given the position of the acetabular components this may well be due to impingement of the femoral neck on the acetabular component.The possibility of abnormal position of the femoral component is less likely.Also possibly contributing to this phenomena would be the patient's activity level with lifestyle choices such as extreme positions in yoga, etc.Having said that, in my experience, with well positioned implants this notching does not occur.The patient should have at the very least, true cross table lateral views to determine the anteversion of the acetabular component and a ct scan to determine both the anteversion of the acetabular component and the femoral component." 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.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17709492
• Report Number: 0002249697-2023-01001
• Device Sequence Number: 14012161
• Product Code: LPH
• UDI-Device Identifier: 07613327037197
• UDI-Public: 07613327037197
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: XR36VL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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: Other
• Patient Sex: Female