MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI INS SZ4 7MM RM/LL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102454407

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The surgeon was unable to set the poly insert in the tibial tray during surgery.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the submitted device noted scratches and gouges on the anterior portion of the distal surface, the anterior proximal edge, and the anterior medial side that are consistent with removal of the insert after unsuccessful attempts to mate the insert to the tray.Review of the device history records did not reveal any manufacturing deviations or anomalies.A worldwide complaint database search found no additional related reports against the complaint sample product code/lot code combination.Deformation observed on the device suggests that the root cause is misalignment of the insert relative to the tray during implantation.No evidence was found indicating product error was a contributing factor to the reported event and the need for corrective action is not indicated.Monitor complaints of assembly problems through sep-419.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI INS SZ4 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: 5993404
• MDR Text Key: 56181981
• Report Number: 1818910-2016-28602
• Device Sequence Number: 1
• Product Code: HRY
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102454407
• Device Lot Number: 535315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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