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 Failure To Adhere Or Bond (1031); Corroded (1131)

Patient Problem No Code Available (3191)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2008, the patient underwent tha with centipillar tmzf and trident cup.After surgery, the surgeon confirmed x-ray.And he found that trident cup was loosening.Therefore the patient underwent the revision surgery on (b)(6) 2016.When the surgeon confirmed remove the implant, the corrosion could be seen in the ceramic liner (outside) and cup (inside).The surgeon changed the implants to brand-new products.The surgeon has finished the surgery.The surgeon requested investigation of the wear of the ceramic liner (outside) and cup (inside).

Manufacturer Narrative

An event regarding corrosion on a trident alumina insert was reported.The event of corrosion was not confirmed, however cup malposition was confirmed.Method & results: -device evaluation and results: visual inspection was carried on the returned part.Very slight marking on inner surface and out surface of liner.A request for a material analysis was reviewed and deemed not required as there was no evidence of corrosion on the liner.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant concluded: procedure-related factors: - cup malposition in excessive anteversion and superficial position.Patient-related factors - none evident.Device-related factors: - none as also supported by the explanted devices.Diagnosis: - cup malposition in excessive anteversion and superficial position has contributed to an overload condition in the arthroplasty causing lack of bone ingrowth fixation of the cup with revision required for gross loosening after 8-years.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: review of the medical records by the clinician indicated "cup malposition in excessive anteversion and superficial position has contributed to an overload condition in the arthroplasty causing lack of bone ingrowth fixation of the cup with revision required for gross loosening after 8-years".No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

On (b)(6) 2008, the patient underwent tha with centpillar tmzf and trident cup.After surgery, the surgeon confirmed x-ray.And he found that trident cup was loosening.Therefore the patient underwent the revision surgery on (b)(6) 2016.When the surgeon confirmed remove the implant, the corrosion could be seen in the ceramic liner(outside) and cup(inside).The surgeon changed the implants to brand-new products.The surgeon has finished the surgery.The surgeon requested investigation of the wear of the ceramic liner(outside) and cup(inside).

• 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: 6070073
• MDR Text Key: 58924314
• Report Number: 0002249697-2016-03435
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 27176101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2008
• 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: 71 YR
• Patient Weight: 48