MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-10-36E

Device Problem Corroded (1131)

Patient Problem Injury (2348)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding revision due to corrosion involving a trident liner was reported.A material analysis conducted on the returned device confirmed that the device was damaged.Method & results: device evaluation and results: a material analysis has been performed.The report stated: "the proximal and articulating surfaces of the insert are noted.Damage was observed on the distal surface of the insert, consistent with impingement.A detailed image of the articulating surface of the insert is noted, with scratching and third-body indentations being observed.This is a common damage mode of uhmwpe." clinical review: not performed as no medical reports were provided.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event reported that the patient was revised due to corrosion.A material analysis conducted on the returned device confirmed that the device was damaged on the distal surface of the insert, consistent with impingement.However the root cause of the event could not be determined as sufficient information was not provided.No further investigation is required at this time.If further information becomes available this investigation will be re-opened.Product surveillance will continue to monitor for trends.Pending investigation closure.

Event Description

Patient was out of the country and required transport back to the us for treatment.Revision hip surgery to remove rejuvenate stem, femoral head and trident polyethylene liner.Rejuvenate neck was separated from stem.Head and neck were still a unit.Re-implant with restoration modular stem and body, biolox femoral head, mdm liner and dall miles cables.Update (b)(4) 2018: as reported in how was issue noticed: patient was sitting in an adirondack style chair.When he rose from the chair, he felt a ¿give¿ in his hip and could not put full weight on his leg.Patient reported to his physician.Update 11/30/2018: as per attached mar dated 20-nov-2018 "the taper lock region of the neck trunnion displayed damage surface morphologies consistent with micro-motion.The discoloration on the taper lock region on the neck trunnion was consistent with a corrosion product, the stem base alloy, and biological material.The micro-motion and corrosion observed on the taper lock region of the neck trunnion is consistent with a mechanically-assisted corrosion process taking place.Damage was observed on the distal surface of the insert, consistent with impingement.".

• Brand Name: TRIDENT 10° X3 INSERT 36MM ID
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8202331
• MDR Text Key: 131591301
• Report Number: 0002249697-2018-04142
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039917
• UDI-Public: 07613327039917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

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 Expiration Date: 07/31/2015
• Device Catalogue Number: 623-10-36E
• Device Lot Number: MJL7R7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• 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: 61 YR
• Patient Weight: 132