MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

A female patient was implanted with a trident psl cup, accolade tmzf stem, ceramic head and liner in 2007.The customer reported that the patient complained of the onset of squeaking of the left hip in (b)(6) 2016 with pain.Revision surgery was undertaken on (b)(6) 2016 and a ceramic head and liner were explanted.The trident cup and accolade stem were left in.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method and results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar).A wear scar was observed on the articulating surface of the insert.The mar concluded : no material or manufacturing defects were observed on the surfaces examined.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.-medical records received and evaluation: a review of the provided x-rays by a clinical consultant concluded: intriguing remains the fact that the problem apparently only started almost 10-years post implantation.The development of a wear scar is then usually the cause for the problem and this is possible after a subluxation of the hip as caused by an extreme manoeuvre in the hip, not reported although oftentimes not even recognized by the patient at the time because problems only develop some time later.This would represent a patient-related factor as root cause but again cannot be confirmed due to lack of information.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and progress notes are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

A female patient was implanted with a trident psl cup, accolade tmzf stem, ceramic head and liner in 2007.The customer reported that the patient complained of the onset of squeaking of the left hip in (b)(6) 2016 with pain.Revision surgery was undertaken on (b)(6) 2016 and a ceramic head and liner were explanted.The trident cup and accolade stem were left in.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6226203
• MDR Text Key: 64018473
• Report Number: 0002249697-2017-00089
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• 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,Followup
• Report Date: 03/24/2017

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: 625-0T-32E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2007
• 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: 35 YR
• Patient Weight: 65