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

Catalog Number 643-00-36F

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Total right hip revision.Surgeon performed poly liner and femoral head swap, to address stability issue in hip joint.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: c-taper cocr lfit head 36mm/-5 ; cat# 06-3699; 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.

• Brand Name: TRIDENT X3 ELEVATED RIM 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18872817
• MDR Text Key: 337292311
• Report Number: 0002249697-2024-00362
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025101
• UDI-Public: 07613327025101
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 643-00-36F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 113 KG