MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; HIP IMPLANT

Catalog Number 71335552

Device Problem Metal Shedding Debris (1804)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/25/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to metalosis.-like symptoms.

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): BROOKS MANUFACTURING SITE; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3921548
• MDR Text Key: 4518466
• Report Number: 1020279-2014-00398
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 71335552
• Device Lot Number: 11BM07317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2014
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71332752-LOT 13EM17430, 71303600-LOT 14AM04641
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR