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	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	03/27/2024
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.The following devices were also listed in this report: it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Original implantation circa 2021.Patient attended routine follow up and x-ray revealed constrained liner defect.Patient was then scheduled for revision surgery, where constrained liner was removed and stryker mdm implanted into the existing cup.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the two x-rays demonstrate a constrained liner with a broken locking ring a tha with a constrained liner with a broken locking ring is confirmed.No documentation regarding revision surgery was provided.The root cause of the defective constrained liner cannot be determined from the limited documentation provided.-device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: the two x-rays demonstrate a constrained liner with a broken locking ring a tha with a constrained liner with a broken locking ring is confirmed.No documentation regarding revision surgery was provided.The root cause of the defective constrained liner cannot be determined from the limited documentation provided.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Original implantation circa 2021.Patient attended routine follow up and x-ray revealed constrained liner defect.Patient was then scheduled for revision surgery, where constrained liner was removed and stryker mdm implanted into the existing cup.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19357960
• Report Number: 0002249697-2024-00765
• Device Sequence Number: 12366136
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 11/30/2025
• Device Catalogue Number: 690-00-22D
• Device Lot Number: TJ2N04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2020
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 129 KG