MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_56MM TRIDENT PSL SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 09/08/2023

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to pain and shell loosening.A shell, liner, and head were revised to another shell, mdm metal liner, adm/ mdm poly insert, and femoral head with sleeve.Rep reported that pictures can be provided.Otherwise, rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown 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: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due pain and shell loosening.A review of the provided medical records by a clinical consultant indicated: this inquiry concerns a 68-year-old gentleman who underwent a primary cementless right total hip arthroplasty in 2010 and then experienced pain and loosening of the shell was diagnosed.A revision was carried out over 13 years later.I can confirm that the patient had a primary total hip arthroplasty since i was able to see an x-ray showing the implant.I cannot confirm the revision since i have no documentation such as office notes, operation notes or post revision x-rays.While i see no definite evidence of loosening on the x-ray supplied, certainly that could be a possibility and it may be more evident on other x-rays.The root cause of loosening of an implant approximately 13 years after implantation is multifactorial including surgical technique factors and patient factors including activity level and bmi.This patient had an elevated bmi at 34.4 with the evidence provided i cannot assign any causality to the implant itself.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination.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 revision 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.

• Brand Name: UNKNOWN_56MM TRIDENT PSL SHELL
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17850769
• MDR Text Key: 324674908
• Report Number: 0002249697-2023-01104
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 115 KG