MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROFIX ZIRCON OX NP FEM SZ5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number 71522257

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/15/2017

Event Type  Injury  

Event Description

It was reported a revision knee surgery was performed due to pain and rubbing.Metallosis was discovered during the revision surgery.

Manufacturer Narrative

Add'l info.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.Please see attached for the summary of our investigation.(b)(4).

• Brand Name: PROFIX ZIRCON OX NP FEM SZ5 LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6688814
• MDR Text Key: 79116769
• Report Number: 1020279-2017-00492
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

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: 06/07/2014
• Device Catalogue Number: 71522257
• Device Lot Number: 04EM07081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 06/08/2017; 06/08/2017
• Supplement Dates FDA Received: 07/06/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2004
• 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); (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention