MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II OXINIUM FEMORAL SIZE 6 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 71420154

Device Problems Mechanical Problem (1384); Unstable (1667)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a revision surgery was performed due to an unstable total knee.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.

• Brand Name: GENESIS II OXINIUM FEMORAL SIZE 6 RIGHT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: claudia de santis ; 1450 brooks road; 0416283206
• MDR Report Key: 6229249
• MDR Text Key: 64063447
• Report Number: 1020279-2017-00017
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2014
• Device Catalogue Number: 71420154
• Device Lot Number: 04GM04372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2004
• 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: INSERT PART#71420778 LOT#04FM20678
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 95