MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER60G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-60G
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional 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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported - the patient presented to the surgeon with hip pain and swelling and the surgeon then decided the patient required a wash out and examination under anaesthetic in theatre.On explantation, several marks were observed on the x3 insert.On dislocation of the implanted primary hip, the surgeon noticed several linear marks on the floor of the x3 insert and on removal it was noticed that there was a linear mark on the biolox head.The surgeon decided that the shell needed to be replaced, so the shell in situ was explanted and replaced with a trident 2 revision shell and two screws.The liner was replaced as was the 36mm biolox head.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device indicated that the device has bone ingrown and damage consistent with time spent implanted and damage 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 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 was revised.The reason for revision was not reported.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 or Problem Description
The following was reported - the patient presented to the surgeon with hip pain and swelling and the surgeon then decided the patient required a wash out and examination under anaesthetic in theatre.On explantation, several marks were observed on the x3 insert.On dislocation of the implanted primary hip, the surgeon noticed several linear marks on the floor of the x3 insert and on removal it was noticed that there was a linear mark on the biolox head.The surgeon decided that the shell needed to be replaced, so the shell in situ was explanted and replaced with a trident 2 revision shell and two screws.The liner was replaced as was the 36mm biolox head.

• Brand Name: TRIDENTII TRITANIUM CLUSTER60G
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 20695729
• Report Number: 0002249697-2024-01572
• Device Sequence Number: 6547049
• Product Code: LPH
• UDI-Device Identifier: 07613327343908
• UDI-Public: 07613327343908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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 Catalogue Number: 702-04-60G
• Device Lot Number: 18966051A
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White