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

Model Number	690-10-22E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a trident liner was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as product was not returned/ remains implanted.  clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation: the revision to a constrained liner was documented and confirmed.The revision of that construct could not be confirmed as there was no actual documentation of the event.There was preoperative evaluations that proposed the procedure.Root cause: the root cause cannot be confirmed without medical records that outlined the revision procedure and examination of the revised implants.The suspicion was that there was impingement, this could/would be confirmed with intraoperative findings.If impingement were the issue it would not likely be a pathologic problem with the implant as it is essentially inherent in the design.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.   complaint history review: there have been no other similar events for the reported lot.  conclusion: the event could not be determined because insufficient information was provided.The medical review indicated: the revision to a constrained liner was documented and confirmed.The revision of that construct could not be confirmed as there was no actual documentation of the event.There was preoperative evaluations that proposed the procedure.The root cause cannot be confirmed without medical records that outlined the revision procedure and examination of the revised implants.The suspicion was that there was impingement, this could/would be confirmed with intraoperative findings.If impingement were the issue it would not likely be a pathologic problem with the implant as it is essentially inherent in the design.Further information such as return of the device, pre- and post-operative x-rays, 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.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient fell in 2018 and has had pain ever since.A stryker constrained liner and competitor femoral head were revised.Rep provided a primary operative report, visit notes, usage sheet, and exam results, and confirmed that no further information will be released by the hospital or surgeon.

• 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: 11729558
• Report Number: 0002249697-2021-00733
• Device Sequence Number: 16928436
• Product Code: KWZ
• UDI-Device Identifier: 07613327024289
• UDI-Public: 07613327024289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 06/30/2017
• Device Model Number: 690-10-22E
• Device Catalogue Number: 690-10-22E
• Device Lot Number: MLJA67
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/26/2021
• 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
• Patient Age: 56 YR
• Patient Weight: 61