MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number 625-0T-32F

Device Problems Degraded (1153); Material Frayed (1262)

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 08/04/2021

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 similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

The surgeon is asking has there been any product warnings on the implants as he sees evidence of metallosis.

Manufacturer Narrative

Patient information, implant and explant dates added.Reported event: an event regarding wear involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The provided photos presented a recent explanted femoral head, a ceramic liner and stem with blood and tissue on it.No conclusive decision can be made on the reported device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's right hip was revised due to metallosis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The surgeon is asking has there been any product warnings on the implants as he sees evidence of metallosis.Update 1 october 2021: there are signs of wear on the trunnion of the accolade tzmf stem even though it was a coc articulation.Noticed when patient reported pain and on scans.Revision completed on (b)(6) 2021.

Manufacturer Narrative

Reported event: an event regarding wear involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the the device indicated no obvious wear is present.Scratch damage is consistent with explantation.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's right hip was revised due to metallosis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The surgeon is asking has there been any product warnings on the implants as he sees evidence of metallosis.Update 1 october 2021: there are signs of wear on the trunnion of the accolade tzmf stem even though it was a coc articulation.Noticed when patient reported pain and on scans.Revision completed on (b)(6) 2021.

• 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12385131
• MDR Text Key: 268710911
• Report Number: 0002249697-2021-01472
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 625-0T-32F
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 33867701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2010
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White