MAUDE Adverse Event Report: STRYKER IRELAND OSTEONICS STYKER ORTHOPAEDICS CLUSTERHOLE ACETABULAR SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number TRIDENT II TRITANIUM 60 MM

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Event Description

Implant was opened onto field.A defect was noticed on the inside of the implant.Implant never touched patient.Fda safety report id# (b)(4).

• Brand Name: STYKER ORTHOPAEDICS CLUSTERHOLE ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER IRELAND OSTEONICS
• MDR Report Key: 12275524
• MDR Text Key: 265169213
• Report Number: MW5102962
• Device Sequence Number: 1
• Product Code: LPH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRIDENT II TRITANIUM 60 MM
• Device Catalogue Number: ALPH CDE: G
• Device Lot Number: 77800401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1