MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ELEVATED RIM 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	643-00-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	09/23/2019
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
It was reported that the patient's left hip was revised due to recurrent dislocations.Surgeon reported complicating factors as patient emaciation with virtually no muscle, and patient non- compliance in terms of follow-up visits.Patient's poly insert and femoral head were revised to an adm/ mdm liner construct with a 28 +4 lfit v40 head.Rep provided a webops report, x-ray, and revision usage sheet, and reported that no further information will be available.
Event or Problem Description
It was reported that the patient's left hip was revised due to recurrent dislocations.Surgeon reported complicating factors as patient emaciation with virtually no muscle, and patient non- compliance in terms of follow-up visits.Patient's poly insert and femoral head were revised to an adm/ mdm liner construct with a 28 +4 lfit v40 head.Rep provided a webops report, x-ray, and revision usage sheet, and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding dislocation involving trident liner was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "rejected for medical review by [.] ¿ x-ray provided confirms dislocation, need additional information; primary and revision operative reports, clinical and past medical history".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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT X3 ELEVATED RIM 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9213364
• Report Number: 0002249697-2019-03555
• Device Sequence Number: 2588646
• Product Code: LPH
• UDI-Device Identifier: 07613327025064
• UDI-Public: 07613327025064
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 04/30/2024
• Device Catalogue Number: 643-00-36E
• Device Lot Number: 8M22K6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: 74 YR
• Patient Weight: 38