MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; TOTAL HIP FEMORAL HEAD

Catalog Number 71342800

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported an outdated product was implanted.

Manufacturer Narrative

The associated complaint device was not returned.The manufacturing records revealed on the label specifications the actual expiration date is 2015/05.A review of complaint history revealed no prior complaints for the listed lot or failure mode.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Type of Device: TOTAL HIP FEMORAL HEAD
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5445766
• MDR Text Key: 38518537
• Report Number: 1020279-2016-00159
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2016

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: 05/28/2015
• Device Catalogue Number: 71342800
• Device Lot Number: 05EM02105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/29/2016; 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2005
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR