MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP TRIDENT ACETABULAR TRIAL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 2210-36E

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Surgeon placing acetabular trial liner into right acetabulum and secured with trial liner screw.It was being removed to place actual acetabular liner when while unscrewing the component cracked off at the screw insertion site.All pieces were removed and retained and available for review.Dr aware and no further action needed.

• Brand Name: TRIDENT ACETABULAR TRIAL
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP
• MDR Report Key: 16380436
• MDR Text Key: 309768844
• Report Number: MW5114955
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• 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: 02/10/2023

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
• Device Model Number: 2210-36E
• Device Catalogue Number: 2210-36E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White