MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22D; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the constrained liner from the shell.Surgeon reported that a contributing factor was that the patient may have not had a full understanding of the available range of motion after hip replacement.The shell and liner were revised to competitor implants.The explants are expected to be available for return and the rep can provide pictures.Rep otherwise confirmed that no further information will be available from the hospital or surgeon.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed.Method & results: product evaluation and results: shell and constrained liner including a v40 metal head were returned for evaluation.Visual inspection of the returned device indicated bone in-growth in the exterior of the device.Damage observed on the exterior which appears consistent with contact with explantation tooling and the time the device spent implanted.The liner was detached from the shell.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as lot code information was unknown.Complaint history review: could not be performed as lot code information was unknown.Conclusions: it was reported that the patient was revised due to disassociation of the liner from the shell.Shell and constrained liner including a v40 metal head were returned for evaluation.Visual inspection of the returned device indicated bone in-growth in the exterior of the device.Damage observed on the exterior which appears consistent with contact with explantation tooling and the time the device spent implanted.The liner was detached from the shell.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.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22673843
• Report Number: 0002249697-2025-00753
• Device Sequence Number: 7412205
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 690-00-22D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Female