MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSABOND AB 40 GRAMS F2; PMMA BONE CEMENT

Catalog Number 71271440

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Information (3190)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an expired batch of bone cement was implanted into the patient.

Manufacturer Narrative

Additional information: type of report, if follow-up, what type?, evaluation codes.The associated device/packaging was not returned, nor was it needed for this investigation.The sterilization shelf life (sled) date for this device is for three years.The device was sterilized/packaged in early 2012, and then used in late 2015; hence the sled date being expired.No further investigation necessary from a manufacturing standpoint.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: VERSABOND AB 40 GRAMS F2
• Type of Device: PMMA BONE CEMENT
• 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 ; 9013991624
• MDR Report Key: 5101237
• MDR Text Key: 26674217
• Report Number: 1020279-2015-00679
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K022688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71271440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other