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 No Pressure (2994); Scratched Material (3020); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was needed due to squeaking hip prosthesis.Customer informed that he decided to replace ceramic abg ii head and trident insert.As per the customer, explanted head shows black marks (scratches) suggesting that there was a particle which got into the prosthesis.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown trident insert.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar)."the articulating surface of the insert contained a region of wear as indicated in figure 7.There was nothing remarkable observed on the exposed surfaces of the sleeve (pn: 625-0t-32e-1)." the mar concluded "no material or manufacturing defects were observed on the device features 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 relevant reported discrepancies.Complaint history review: review indicated there has 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 device features examined".The exact cause of the event however could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

It was reported that revision surgery was needed due to squeaking hip prosthesis.Customer informed that he decided to replace ceramic abg ii head and trident insert.As per the customer, explanted head shows black marks (scratches) suggesting that there was a particle which got into the prosthesis.

Manufacturer Narrative

An event regarding audible noise involving an unknown trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review could not be performed as the device details are unknown.Complaint history review could not be performed as the device details are unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

It was reported that revision surgery was needed due to squeaking hip prosthesis.Customer informed that he decided to replace ceramic abg ii head and trident insert.As per the customer, explanted head shows black marks (scratches) suggesting that there was a particle which got into the prosthesis.

• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4760504
• MDR Text Key: 5784114
• Report Number: 0002249697-2015-01470
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 45696201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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