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-28D

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

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 following was reported: a surgery to remove and replace the ceramic liner was performed based on the ct data, which appeared to be damaged liner.A hard object was found during the procedure.Can you please investigate whether the alumina ceramic liner is damaged and what the hard object is? reason for revision was due to pain.

Manufacturer Narrative

Reported event: an event regarding damage involving a trident liner was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with explantation.No wear was observed on the device.No further surface discrepancies were observed.-clinician review: a review of medical records with a clinical consultant indicated " conclusion/assessment: by report a revision surgery was performed based on a ct scan that seemed to indicate bearing fracture.As noted in the narrative, the ct image appeared to show debris or fragments of some kind in the joint.The radiographic density of the fragments seem more than the head.The origin of the debris, if present, is unclear.No conclusions may be drawn from the x-rays or report without additional medical information.Event confirmation: the event cannot be confirmed without additional medical information.Root cause: a root cause cannot be ascertained without additional medical information." -product history review: review of the device history records indicate the devices were manufactured and accepted into final stock on 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 was revised.Visual inspection of the returned device indicated that the device had scratches/nicks on the metal and ceramic surfaces.Damage is consistent with explantation.No wear was observed on the device.No further surface discrepancies were observed.A review of medical records with a clinical consultant indicated " conclusion/assessment: by report a revision surgery was performed based on a ct scan that seemed to indicate bearing fracture.As noted in the narrative, the ct image appeared to show debris or fragments of some kind in the joint.The radiographic density of the fragments seem more than the head.The origin of the debris, if present, is unclear.No conclusions may be drawn from the x-rays or report without additional medical information.Event confirmation: the event cannot be confirmed without additional medical information.Root cause: a root cause cannot be ascertained without additional medical information." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The following was reported: a surgery to remove and replace the ceramic liner was performed based on the ct data, which appeared to be damaged liner.A hard object was found during the procedure.Can you please investigate whether the alumina ceramic liner is damaged and what the hard object is? reason for revision was due to pain.

• 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: 16383676
• MDR Text Key: 309635265
• Report Number: 0002249697-2023-00163
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516831
• UDI-Public: 04546540516831
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 625-0T-28D
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 42254903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• 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
• Patient Age: 62 YR
• Patient Sex: Female