MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI INS SZ5 7MM RM/LL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102454507

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Surgeon attempted to implant the tibial insert into the tibial tray but it would not seat.Insert was removed and the tray was carefully inspected to see if any bone or soft tissue was obstructing the insert from going in.After careful inspection another insert was opened and attempted to implant it.The second insert also wouldn't go into the tray.Finally a third insert was opened and it went into the tray easily.

Manufacturer Narrative

Visual examination of the two submitted device revealed witness lines on the distal surface running parallel to the medial edge and contained within a boundary roughly 1mm from the edge.This damage is consistent with the medial locking edge not properly sliding into the groove of the tray during insertion.These observations indicate the inserts were not optimally aligned relative to the tibial tray prior to assembly.Review of the device history records did not reveal any manufacturing deviations or anomalies.The root cause is attributed to user technique.No evidence was found of product error as a contributing factor to the reported events and the need for corrective action is not indicated.Monitor complaints through sep-419.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIGMA HP UNI INS SZ5 7MM RM/LL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6222573
• MDR Text Key: 63859025
• Report Number: 1818910-2017-10163
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 102454507
• Device Lot Number: 703524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• 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