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

Model Number	690-10-22F
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
The patient underwent surgery on march 10for the placement of stryker products (torx & trident).On 05/21, she was admitted to the hospital for a dislocation.When performing x-ray, she observed stryker product failure.The patient undergoes urgent revision surgery.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident constrained liner 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: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the 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's hip was revised due to dislocation.It's not clear which components were dislocated/ disassociated.An off label use was also reported.It was reported that the device was used with competitor stem and femoral head.A review of ifu, qin 4357, rev aa, which was packaged with the device at the time of manufacture noted the following in warnings section that "do not substitute another manufacturer¿s device for any component of the howmedica osteonics total hip system.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The patient underwent surgery on (b)(6) 2021 for the placement of stryker products (torx & trident).On (b)(6) 2021, she was admitted to the hospital for a dislocation.When performing x-ray, she observed stryker product failure.The patient undergoes urgent revision surgery.

• Brand Name: TRIDENT CONSTRAINED INSERT
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12030830
• Report Number: 0002249697-2021-01049
• Device Sequence Number: 16374891
• Product Code: KWZ
• UDI-Device Identifier: 07613327024357
• UDI-Public: 07613327024357
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 12/31/2023
• Device Model Number: 690-10-22F
• Device Catalogue Number: 690-10-22F
• Device Lot Number: YR01E5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention