MAUDE Adverse Event Report: DEPUY ORTHOPEDICS INC. DEPUY ASR XL; ACETABULAR CUP, SIZE 54

Catalog Number 9998-00-754

Device Problem Device Issue (2379)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Patient had revision of left total hip replacement for removal of a depuy asr articular liner.Reference mfr # 1818910-2015-25636.

• Brand Name: DEPUY ASR XL
• Type of Device: ACETABULAR CUP, SIZE 54
• Manufacturer (Section D): DEPUY ORTHOPEDICS INC.; warsaw IN 46582
• MDR Report Key: 4916153
• MDR Text Key: 15840480
• Report Number: 4916153
• 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: 06/19/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2011
• Device Catalogue Number: 9998-00-754
• Device Lot Number: 2177776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR