MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG - SWITZERLAND BICON-PLUS TITANIUM SHELL 3-49 NON-CEM; HIP IMPLANT

Catalog Number 75003740

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 03/31/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to aseptic loosening.

• Brand Name: BICON-PLUS TITANIUM SHELL 3-49 NON-CEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG - SWITZERLAND; schachenallee 29; aarau ; SZ
• Manufacturer (Section G): SMITH & NEPHEW, INC.- SWITZERLAND; schachenallee 29; aarau ; SZ
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 3761065
• MDR Text Key: 4486203
• Report Number: 9613369-2014-00061
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2015
• Device Catalogue Number: 75003740
• Device Lot Number: D0808014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2008
• 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: (B)(4), LOT# H0807610
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 95