MAUDE Adverse Event Report: DEPUY ORTHOPEDICS (USA) ANTERIOR CORAIL/TRI-LOCK; TRILOCK STEM INSERTION DEVICE

Catalog Number D259807440

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

Tip of femoral inserter broke off in pt.Unable to remove due to piece is lodged within the femoral component implant.Entire implant would have to be removed to obtain broken piece.

• Brand Name: ANTERIOR CORAIL/TRI-LOCK
• Type of Device: TRILOCK STEM INSERTION DEVICE
• Manufacturer (Section D): DEPUY ORTHOPEDICS (USA); warsaw IN
• MDR Report Key: 6375787
• MDR Text Key: 69147670
• Report Number: MW5068223
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D259807440
• Device Lot Number: PG0208
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 99