MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-28F
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: the patient presented at the hospital on (b)(6) 2022, her hip prosthesis had dislocated.Specifically, she had a trident constrained insert in-situ and the bipolar head had dislocated from the insert that it had been pre-assembled in.The insert was still in the acetabular shell, but the bipolar head was completely disengaged from it.The bipolar head still had the femoral head within it, which itself was still intact on the cone body implant trunnion.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results -product evaluation and results: the constrained liner including the uhr bipolar head was returned for evaluation.The uhr bipolar head assembled with ceramic head has disassociated from the poly liner.The outer ring has separated from the constrained liner.Visual inspection of the returned device indicated damage resulting from explantation.Dimensional inspection was not performed because the device was returned damaged and would not be reflective of its original manufactured condition.-clinician review: a review of the provided medical records by a clinical consultant indicated: according to the summary provided, this patient underwent a revision total hip arthroplasty using a restoration modular femoral implant with a constrained acetabular liner.The patient subsequently sustained a dislocation/disassociation of the bipolar component from the constrained liner.I can confirm that this event occurred since i was able to see an x-ray with the dislocation present although no date or demographic information was present on the x-ray.The causes of early dislocation/disassociation of a bipolar femoral component from a constrained liner are multifactorial including surgical technique factors such as proper assembly of the construct, patient factors including activity level and bmi and reliability of following postoperative instructions, as well as implant factors.I cannot determine the root cause of this event with certainty.At this point i would not assign any causality to the implant itself.-product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported the constrained liner disassociated.A review of the provided medical records by a clinical consultant indicated: according to the summary provided, this patient underwent a revision total hip arthroplasty using a restoration modular femoral implant with a constrained acetabular liner.The patient subsequently sustained a dislocation/disassociation of the bipolar component from the constrained liner.I can confirm that this event occurred since i was able to see an x-ray with the dislocation present although no date or demographic information was present on the x-ray.The causes of early dislocation/disassociation of a bipolar femoral component from a constrained liner are multifactorial including surgical technique factors such as proper assembly of the construct, patient factors including activity level and bmi and reliability of following postoperative instructions, as well as implant factors.I cannot determine the root cause of this event with certainty.At this point i would not assign any causality to the implant itself.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.
Event or Problem Description
The following was reported: the patient presented at the hospital on (b)(4) 2022, her hip prosthesis had dislocated.Specifically, she had a trident constrained insert in-situ and the bipolar head had dislocated from the insert that it had been pre-assembled in.The insert was still in the acetabular shell, but the bipolar head was completely disengaged from it.The bipolar head still had the femoral head within it, which itself was still intact on the cone body implant trunnion.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• 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: 16173671
• Report Number: 0002249697-2023-00048
• Device Sequence Number: 19409220
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 690-00-28F
• Device Catalogue Number: 690-00-28F
• Device Lot Number: WP4K56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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: 81 YR
• Patient Sex: Female