MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT ANTERIOR INSERTER SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Lot Number 2598-07-450

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Patient presented for elective total hip arthroplasty, post operative x-rays showed a retained small metal piece which was identified as the tip of an anterior inserter instrument.Fda safety report id# (b)(4).

• Brand Name: SUMMIT ANTERIOR INSERTER SHAFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 12952694
• MDR Text Key: 281937528
• Report Number: MW5105838
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2598-07-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White