MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI INS SZ5 8MM RM/LL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102454408

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 10/22/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Examination of the returned device found evidence consistent with unsuccessful attempts to assemble the tibial insert to the tray.A device history record review 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 at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Surgeon reported the rm poly wasn't machined correctly to fit the tibia.

• Brand Name: SIGMA HP UNI INS SZ5 8MM RM/LL
• 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. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5257023
• MDR Text Key: 32357984
• Report Number: 1818910-2015-32720
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

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: 01/09/2016
• Device Catalogue Number: 102454408
• Device Lot Number: FB1N41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2011
• 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: 64 YR