MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. LPT GREAT TOE IMPLANT; SMALL JOINT COMPONENT

Catalog Number 487-S000

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2015

Event Type  Injury  

Event Description

Allegedly, implant was implanted 3 months after expiry date.The date of the original surgery (b)(6) 2015.A sales representative was present during the procedure.There surgery did not extend over 30 minutes.Additional information received via email on 7/1/2015 from michel fleury: in israel a hospital implanted a lpt implant that was expired on march 2015.Implantation site/procedure: hmiarthoplasty.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

Manufacturer Narrative

Investigation complete, the product was sold by wright medical well before the expiration date.The expiration of the implant was not noticed either by the distributor or the hospital before implantation.There were no complaints related to infection that was received by wright medical , after implantation of this particular expired product.

• Brand Name: LPT GREAT TOE IMPLANT
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901867-414
• MDR Report Key: 4939093
• MDR Text Key: 6194976
• Report Number: 1043534-2015-00045
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K864492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 487-S000
• Device Lot Number: 037406666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other