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-32F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/22/2014

Event Type  Injury  

Manufacturer Narrative

An event regarding seating/locking issues involving an trident liner was reported.A review by a clinical consultant confirmed a seating/locking issue but did not confirm altr.Method & results: -device evaluation and results: not performed as no items were returned.-medical records received and evaluation: revision of accolade ii stem due to pain of the patient with suspected stem loosening some 20-months post implantation in a (b)(6) -year (1984) old male patient with a moderate overweight condition (bmi = (b)(6)).No trauma or other adverse event reported.The stem was replaced with a restoration modular (rm) device.X-rays confirm implantation of an accolade ii stem in adequate size and stable position.Also the cup has an adequate position but the ceramic trident liner is incompletely seated in the trident shell.This does not change over time.At 5-months post implantation an ultrasound scan confirms fluid is still present in and around the arthroplasty.X-rays at 1½-year post implantation still show an unchanged stem position with bone reactive lines around the distal stem section but not around the proximal stem area.No further clinical information is available while pictures of the explanted accolade stem document some fibrous tissue on the ingrowth surface with otherwise explantation damage on the trunnion.- on the other hand, based upon x-ray information, the stem appears stable in the bone.There was no subsidence with time while at 1½-year post implantation bone reactive lines were visible around the distal stem section but not around the proximal stem area.- even with the limited information present, such a failure scenario as a consequence of an unstable ceramic liner is much more plausible than a primary bone fixation failure which is pretty rare for modern ha-coated stems unless under gross overload conditions.Both timing of symptoms, the fluid in the joint at 5-months, the radiological evidence for incomplete seating of the liner plus the reasonably good mechanical stability of the stem even at 1½-years are much more consistent with a liner seating problem than anything else while the fibrous fixation of the stem then is secondary to this liner seating problem from the adverse biological effects of same.- in summary, although the exact cause of the problem cannot be completely resolved due to lack of proper information, it is quite certain that the liner seating problem has been caused by an adverse mix of predominantly procedure-related factors with possibly a dense bone quality factor as a potential additional patient-related factor as discussed.The adverse biological environment associated with this problem has quite likely impaired bony ingrowth fixation of the stem as secondary effect.This pi case is not device-related.Procedure-related factors: - incomplete trident liner seating.Patient-related factors: - moderate overweight (bmi = (b)(6)) not very relevant.- possibly high bone mineral density.Device-related factors: - none.Diagnosis: - incomplete trident liner seating has likely contributed to micro motion between liner and shell with local metal ion release causing pain symptoms while impairing adequate bony fixation of the stem.-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 events for the reported lot.Conclusions: a review by a clinical consultant concluded "incomplete trident liner seating has likely contributed to micro motion between liner and shell with local metal ion release causing pain symptoms while impairing adequate bony fixation of the stem.If further relevant information becomes available including pathology reports or the product is returned this investigation will be re-opened.Device not returned.

Event Description

The customer reported loosening with the accolade stem.The patient underwent primary surgery - thr - on (b)(6) 2013 and was revised in (b)(6) 2014.The patient has a bmi of (b)(6).Update: the customer reported that he has experienced increasing pain, and that there were no precipitating factors, such as a fall or trauma hospital correspondence confirms the date of revision as (b)(6) 2014.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6201291
• MDR Text Key: 63174115
• Report Number: 0002249697-2016-04010
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2016

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: 12/30/2015
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 35508302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2010
• 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): Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 103