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-36G

Device Problems Degraded (1153); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Swelling (2091); Injury (2348)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The sales representative reported on behalf of the surgeon that the patient, who had initially presented with pain and swelling in the groin, underwent revision surgery on (b)(6) 2016.The patient had been implanted with an exeter stem, trident cup, ceramic liner and alumina head in approximately 2005 by a surgeon who since retired.The new surgeon initially suspected when the patient presented with symptoms that there may have been an issue with ceramic head and as such he carried out an anterior pelvic exploration and pseudo tumour debridement.On exploration it became apparent that the cup was too large for the patient's anatomy and had been rubbing against the patients tendon, causing the swelling.As such the surgeon went in posteriorly to carry out the revision.All devices were explanted successfully.The surgeon commented after the devices had been removed that there did not appear to be anything wrong with the ceramic and there appeared to be corrosion on the trunnion of the stem.The representative was in the case and commented that the trunnion looked worn, although he did not observe any corrosion.

Manufacturer Narrative

An event regarding altr (psuedotumour) involving an trident liner was reported.Altr could not be confirmed as medical records were not provided.Method and results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), images of the device are included in the mar.""the proximal and articulating surfaces of the insert were inspected.The outer rim of the insert with debris was also being observed" a material analysis concluded: "no material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a medical review was not performed because insufficient information was provided.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: a material analysis was performed and concluded that " no material or manufacturing defects were observed on the surfaces examined." the exact cause of the event however could not be determined because insufficient information was provided.Additional information, including operative reports, pathology reports, progress notes and serial x-rays are needed to fully investigate the event.If further information becomes available investigation will be re-opened.

Event Description

The sales representative reported on behalf of the surgeon that the patient, who had initially presented with pain and swelling in the groin, underwent revision surgery on (b)(6) 2016.The patient had been implanted with an exeter stem, trident cup, ceramic liner and alumina head in approximately 2005 by a surgeon who since retired.The new surgeon initially suspected when the patient presented with symptoms that there may have been an issue with ceramic head and as such he carried out an anterior pelvic exploration and pseudo tumour debridement.On exploration it became apparent that the cup was too large for the patient's anatomy and had been rubbing against the patients tendon, causing the swelling.As such the surgeon went in posteriorly to carry out the revision.All devices were explanted successfully.The surgeon commented after the devices had been removed that there did not appear to be anything wrong with the ceramic and there appeared to be corrosion on the trunnion of the stem.The representative was in the case and commented that the trunnion looked worn, although he did not observe any corrosion.

• 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: 5452065
• MDR Text Key: 38744781
• Report Number: 0002249697-2016-00495
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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: 03/31/2013
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 26222002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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