MAUDE Adverse Event Report: STRYKER IRELAND OSTEONICS INSIGNIA, TRIDENT HEAD TRIALS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problems Break (1069); Leak/Splash (1354); Defective Component (2292)

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

Event Type  malfunction  

Event Description

Stryker hip head trials have a red rubber ring located inside the trial there is a clear coating that covers the red ring, the clear coating tears often and allows blood to get between the clear coating and the rubber ring.If this goes unnoticed by the hospital employee there is an elevated risk of the pt.Acquiring an ssi local sales rep has filed a complaint at my request with stryker, stryker's reply was to keep submitting complaints.Fda safety report id #(b)(4).

• Brand Name: INSIGNIA, TRIDENT HEAD TRIALS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER IRELAND OSTEONICS
• MDR Report Key: 15428062
• MDR Text Key: 300188716
• Report Number: MW5112049
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other