MAUDE Adverse Event Report: DEPUY ORTHOPEDICS, INC. DEPUY ASR XL

Model Number 9998-90-247

Device Problem Device Issue (2379)

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

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Pt had revision of right total hip replacement due to adverse reaction to metal and articular wear.Pt had elevated ion levels.Depuy asr uni-femoral implant, ref: 9998-90-247; lot 2484665, size 47, exp 2012-10.

• Brand Name: DEPUY ASR XL
• Type of Device: ASR XL
• Manufacturer (Section D): DEPUY ORTHOPEDICS, INC. ; warsaw IN 46582
• MDR Report Key: 5417158
• MDR Text Key: 37720417
• Report Number: 5417158
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2012
• Device Model Number: 9998-90-247
• Device Catalogue Number: 9998-90-247
• Device Lot Number: 2484665
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2016
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 97