MAUDE Adverse Event Report: DEPUY ORTHOPEDICS RIGHT HIP IMPLANT

Device Problems Metal Shedding Debris (1804); Implant, removal of (2320)

Patient Problems Failure of Implant (1924); Arthralgia (2355)

Event Date 07/07/2016

Event Type  Injury  

Event Description

Wear of articular bearing surface of internal prosthetic right hip joint with elevated metal level(s) right hip failed metal on metal total hip.Ref mfr #1818910-2016-24600, 1818910-2016-24602.

• Brand Name: RIGHT HIP IMPLANT
• Type of Device: RIGHT HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPEDICS ; warsaw IN
• MDR Report Key: 5853009
• MDR Text Key: 51372461
• Report Number: 5853009
• Device Sequence Number: 1
• Product Code: KWA
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2016
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2016
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 95