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-36H
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the patient required revision hip surgery following identification of elevated ti levels and a worn (titanium sleeve portion) of a ceramic liner had to be removed in addition to an alumina head.It was further reported that the patient was revised using a new poly liner coupled with a c taper sleeve and delta 36mm head.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: inspection of the returned device noted that no excessive wear was identified on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the revision of a total hip replacement due to elevated titanium ion levels and a worn titanium sleeve.I cannot confirm that this event took place since i was not able to see any medical documentation, office notes, operation report, or photos of the explanted devices.Regarding the possible root cause of this event, i cannot determine it with certainty.In my experience this an extremely rare occurrence but possible causes may be due to surgical technique factors, implant factors, and patient factors.-product history review: review of the device history records indicate 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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as medical documentation, office notes, operation report are needed to complete the investigation for determining root cause.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 or Problem Description
It was reported that the patient required revision hip surgery following identification of elevated ti levels and a worn (titanium sleeve portion) of a ceramic liner had to be removed in addition to an alumina head.It was further reported that the patient was revised using a new poly liner coupled with a c taper sleeve and delta 36mm head.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12104530
• Report Number: 0002249697-2021-01124
• Device Sequence Number: 17089390
• Product Code: MRA
• UDI-Device Identifier: 04546540516879
• UDI-Public: 04546540516879
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2011
• Device Model Number: 625-0T-36H
• Device Catalogue Number: 625-0T-36H
• Device Lot Number: 18002001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female