MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. DEPUY; FEMORAL HEAD, SIZE 53

Catalog Number 9998-90-253

Device Problem Device Issue (2379)

Patient Problems Failure of Implant (1924); Reaction (2414)

Event Date 07/28/2014

Event Type  Injury  

Event Description

Patient had revision of right total hip replacement due to adverse reaction to metal implants and recalled implant.Reference mfr# 1818910-2015-12522.

• Brand Name: DEPUY
• Type of Device: FEMORAL HEAD, SIZE 53
• Manufacturer (Section D): DEPUY ORTHOPEDICS, INC.; warsaw IN 46582
• MDR Report Key: 4484152
• MDR Text Key: 5333795
• Report Number: 4484152
• Device Sequence Number: 1
• Product Code: LZO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 9998-90-253
• Device Lot Number: 2731649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 88