MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI INS SZ3 8MM LM/RL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453308

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/21/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Poly insert does not fully engage.

Manufacturer Narrative

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 returned sigma hp uni ins sz3 8mm lm/rl found evidence consistent with unsuccessful attempts to assemble the tibial insert to the tray.Product development engineering conducted a design/drawing review which did not reveal any information that would suggest the product design or design drawing were contributing factors to the reported assembling difficulties.No other complaints were found during a 2 year database search against the provided lot found.A dhr was conducted and no anomalies were found.Although no root cause was conclusively determined, suspected user technique is a possible contributing factor to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action is not indicated.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

• Brand Name: SIGMA HP UNI INS SZ3 8MM LM/RL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4290894
• MDR Text Key: 16019066
• Report Number: 1818910-2014-33017
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2014

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 Expiration Date: 06/30/2018
• Device Catalogue Number: 102453308
• Device Lot Number: 399063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2014; 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2013
• 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
• Patient Age: 45 YR