MAUDE Adverse Event Report: DEPUY RAYNHAM-REG. # 1219655 SIGMA HP UNI INS SZ4 9MM RM/LL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102454409

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/23/2016

Event Type  malfunction  

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.

Event Description

The insert would not snap in and lock to the fixed bearing tray.

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 found damage consistent with unsuccessful attempts to assemble the device into the tibial tray.The deformation observed suggests that the root cause is misalignment of the insert relative to the tray during implantation.Requests for additional investigational inputs were made in accordance with (b)(4) appendix a.No additional information was obtained.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.The root cause is attributed to user error/technique.No evidence was found indicating product error was a contributing factor to the reported event and the need for corrective action is not indicated.Depuy considers the investigation closed.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 SZ4 9MM RM/LL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY RAYNHAM-REG. # 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5980253
• MDR Text Key: 55726795
• Report Number: 1818910-2016-28156
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102454409
• Device Lot Number: 188464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/07/2016; 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2012
• 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