MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT DEPUY STEM & ASR DEPUY CUP; ACETABULAR CUP, FEMUR HEAD

Device Problems Explanted (1217); Device Issue (2379)

Patient Problem Pain (1994)

Event Date 02/09/2016

Event Type  Injury  

Event Description

Right hip dislocation, leading to acetabular components dislocation removal and replacement of components required.Ref # 1818910-2016-14606.

• Brand Name: SUMMIT DEPUY STEM & ASR DEPUY CUP
• Type of Device: ACETABULAR CUP, FEMUR HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedics drive; warsaw IN 46582
• MDR Report Key: 5479641
• MDR Text Key: 39745115
• Report Number: 5479641
• Device Sequence Number: 1
• Product Code: KXA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2016
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• 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): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 45