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 Break (1069); Fracture (1260); Noise, Audible (3273)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

The patient reported that he felt discomfort in the hip and that heard noises during the movement.The doctor made an x-ray and found on the physical examination that it was a possible break in the insert.A revision surgery was performed on (b)(6) 2018 and the broken component (insert) was replaced.

Event Description

The patient reported that he felt discomfort in the hip and that heard noises during the movement.The doctor made an x-ray (attached) and found on the physical examination that it was a possible break in the insert.A revision surgery was performed on 3/31/2018 and the broken component (insert) was replaced.

Manufacturer Narrative

An event regarding crack/fracture, pain and audible noise involving a trident liner was reported.Crack/fracture was confirmed by the photos provided and by medical review but pain and audible noise could not be confirmed.Method & results: -product evaluation and results: the device was not returned but a photo of the explanted device was provided.The photo shows that the ceramic part of the device has fractured into a number of pieces.All of the ceramic pieces have been removed from the outer metal of the liner.There is significant scratching on the inside of the metal along with some damage on the outer rim.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: narrative: patient underwent an index tha on 5/12/2014.Developed pain.Pre revision x-rays demonstrate fragmentation of the acetabular ceramic insert.Photographs of the explanted insert and shell show the intact shell and fractured insert.Post-operative x-rays of the tha with revised acetabulum that appears well fixed and in satisfactory alignment and orientation.Assessment: the primary harm involved is mechanical failure of an alumina ceramic acetabular insert.Further documentation which would aid in the further completion of this assessment would include: operative reports, outpatient office/clinic notes and implant retrieval -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the medical review concluded the following: the primary harm involved is mechanical failure of an alumina ceramic acetabular insert.Further documentation which would aid in the further completion of this assessment would include: operative reports, outpatient office/clinic notes and implant retrieval no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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
• MDR Report Key: 7459360
• MDR Text Key: 106459670
• Report Number: 0002249697-2018-01239
• 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
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 42619401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 95