MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 702-04-52E

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/21/2022

Event Type  Injury  

Event Description

As reported: "patient's right hip revised due to cup being loose." a shell, mdm metal liner, adm/ mdm poly insert and ceramic femoral head were revised.

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.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.Device not returned to the manufacturer.

Event Description

As reported: "patient's right hip revised due to cup being loose." a shell, mdm metal liner, adm/ mdm poly insert and ceramic femoral head were revised.

Manufacturer Narrative

An event regarding loosening involving a trident ii shell was reported.The event was not confirmed.Method & results -product 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 indicated: relevant clinical history: undated/unlabeled ap pelvis x-ray: a notation po 2.5 yrs was included.The x-ray showed spinal hardware.There are large lytic areas in the peri-trochanteric region of the femur but the stem does not appear to be loose or subsided.The acetabular implant has a large inferior lucency and a near complete lucent line.The cup appears somewhat medialized.An acetabular fracture cannot be ruled out.The head seems a bit eccentric.Narrative: no real claims may be made without additional materials.The acetabular component appears loose on a single x-ray view.The amount of lysis in the femur and changes around the cup seem quite severe for an implant only 2.5 years old.By report the acetabulum was revised.Adverse event identified: loosening of the acetabulum with revision arthroplasty, but the event cannot be confirmed.Confirmation: the event cannot be confirmed without additional medical information and history.Conclusion of assessment: no conclusions may be made without additional medical information -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 due to loosening of a trident ii shell.The event was not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENTII TRITANIUM CLUSTER52E
• Type of Device: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16156336
• MDR Text Key: 307259988
• Report Number: 0002249697-2023-00040
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327343915
• UDI-Public: 07613327343915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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
• Device Operator: Health Professional
• Device Model Number: 702-04-52E
• Device Catalogue Number: 702-04-52E
• Device Lot Number: 75971601A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female