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 Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.The following devices were also listed in this report: unknown cork product; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Fractured ceramic liner component.Patient states he was bending over and heard a click.Has been walking around on it for weeks before presenting to hospital.Patient requiring revision surgery to remove the broken component.Tissue metallosis evident.

Event Description

Fractured ceramic liner component.Patient states he was bending over and heard a click.Has been walking around on it for weeks before presenting to hospital.Patient requiring revision surgery to remove the broken component.Tissue metalosis evident.

Manufacturer Narrative

An event regarding crack/fracture & altr involving a trident liner was reported.Crack/fracture was confirmed by material analysis.Altr was not confirmed.Method & results: -device evaluation and results: a visual inspection was performed by a material analysis engineer which noted; the trident alumina insert is composed of a titanium sleeve and ceramic insert.The ceramic insert had fractured, likely during in-vivo use.The proximal and distal surface of the titanium sleeve are shown.The titanium sleeve was observed to have explantation damage and damages consistent with contact against the femoral head and ceramic insert fragments.The ceramic insert fragments that were returned are shown.The fragments were observed to have metal transfer marks, post fracture chipping and abrasion which obscured the fracture surface and prevented further analysis.A material analysis concluded that the ceramic insert fractured likely during in-vivo use and was observed to have post fracture chipping and abrasion, obscuring the fracture surface and prevented further analysis.The fracturing of the ceramic insert allowed the femoral head, titanium sleeve and ceramic insert fragments to contact against each other, causing the damages observed.A continuous metal transfer ring was observed at the proximal end of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant noted i have seen the info for this patient with trident ceramic bearing fracture.There is a primary arthroplasty report for the right hip on (b)(6) 2014, to document implantation of a trident 56-mm shell with 32-mm ceramic bearing plus an exeter stem 44/no-3 with zirconia 32/-4 femoral head.No issues or complications.The explant photographs confirm the ceramic bearing fracture, the zirconia head still appears intact.There is no other clinical information and no x-rays.As such is there no further information about the conditions surrounding the event.Problems with fracture of ceramic components are often associated with suboptimal component position, frequently the cup.Without explicit radiological information can such cases therefore not be solved that also applies to this case.More info, especially x-rays, are required to help solve this case.-device history review: a dhr review found that all devices in the lot referenced were accepted into final stock with no relevant reported discrepancies.-complaint history review: there were no similar events for the lot id referenced.Conclusions: a material analysis reported concluded that the ceramic insert fractured likely during in-vivo use and was observed to have post fracture chipping and abrasion, obscuring the fracture surface and prevented further analysis.The fracturing of the ceramic insert allowed the femoral head, titanium sleeve and ceramic insert fragments to contact against each other, causing the damages observed.A continuous metal transfer ring was observed at the proximal end of the female taper consistent with proper seating between of the trunnion of the hip stem and the head taper.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined.Further information such as x-rays and operative reports are required to investigate further.If additional information is received this investigation 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: 7268253
• MDR Text Key: 99961659
• Report Number: 0002249697-2018-00411
• 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: 04/24/2018

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: 11/30/2019
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 46607304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 105