MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	723-00-36D
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away." the head partially came off the trunnion because of the wear.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away." the head partially came off the trunnion because of the wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed via review of the provided photograph.Method & results: product evaluation and results: the device was not returned for inspection; however.A photograph was provided.The photograph shows a recently explanted liner with signs of wear.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported that the patient's right hip was revised.As reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away." the device was not returned for inspection; however.A photograph was provided.The photograph shows a recently explanted liner with signs of wear.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.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36D
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21384854
• Report Number: 0002249697-2025-00205
• Device Sequence Number: 20947796
• Product Code: LPH
• UDI-Device Identifier: 07613327296990
• UDI-Public: 07613327296990
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 723-00-36D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 72 KG