MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-10-36F

Device Problems Degraded (1153); Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

An event regarding instability and wear involving a trident 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 devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar event for the reported lot.Conclusions: it was reported that the patient's hip was revised due to instability and wear.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.The following devices were also listed in this report: unknown biolox 36 -5 femoral head; cat# unknown; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned to the manufacturer.

Event Description

It was reported that the patient's right hip was revised due to instability and wear of the liner.A head and liner exchange was performed.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 10° X3 INSERT 36MM ID
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17047604
• MDR Text Key: 316394979
• Report Number: 0002249697-2023-00612
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2023

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 Expiration Date: 06/30/2013
• Device Model Number: 623-10-36F
• Device Catalogue Number: 623-10-36F
• Device Lot Number: AKTMKE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2008
• 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): Hospitalization; Required Intervention
• Patient Sex: Female