MAUDE Adverse Event Report: SMITH&NEPHEW, INC BICON CUP STANDARD; BICON-PLUS TITANIUM SHELL 5-56 NON-CEM

Catalog Number 75003742

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

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

• Brand Name: BICON CUP STANDARD
• Type of Device: BICON-PLUS TITANIUM SHELL 5-56 NON-CEM
• Manufacturer (Section D): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer (Section G): SMITH&NEPHEW, INC; schachenallee 29; aarau CH50 00; SZ CH5000
• Manufacturer Contact: phillip emmert ; 1450 e. brooks rd; memphis, TN 38116 ; 9013995296
• MDR Report Key: 3994411
• MDR Text Key: 20783317
• Report Number: 9613369-2014-00082
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2014
• Device Catalogue Number: 75003742
• Device Lot Number: D0706815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2007
• 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) - SL-PLUS STANDARD STEM 5- (B)(4); (B)(4) - CERAMIC BALL HEAD 32M - (B)(4); (B)(4) - BICON-PLUS PE INSERT - (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 95