MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI INS SZ4 11MM LMRL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453411

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 05/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Conclusion and justification status for mdr: examination of the submitted device confirmed damage consistent with unsuccessful attempts to assemble with a tibial tray.Review of the device history records did not reveal any manufacturing deviations or anomalies.There is significant damage to the posterior aspect of the insert.The damage suggests the insert was not properly aligned with the tibial tray prior to attempted assembly.No evidence was found suggesting product error was a contributing factor and 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.(b)(4).

Event Description

The insert would not lock completely after numerous attempts.The size of the insert was changed, a size 10 was used.This new insert was inserted without an issue.

• Brand Name: SIGMA HP UNI INS SZ4 11MM LMRL
• 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: 5264661
• MDR Text Key: 32623004
• Report Number: 1818910-2015-32749
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2014

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: 08/31/2016
• Device Catalogue Number: 102453411
• Device Lot Number: 138499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2011
• 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: 59 YR