MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CR FEM TRIAL SZ 8 LT; KNEE INSTRUMENT/TRIAL

Catalog Number 254500718

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A large piece of the attune trial has broken off.This case has been reported by the loan kit technician during loan kit inspection.

Manufacturer Narrative

The device associated with this report was not returned.Follow up communication for product return was unsuccessful.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

The investigation has been reopened because the product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Examination of the returned device confirms the reported event of trial breakage.With the provided information, a definitive root cause is unknown.(b)(4) was performed by commercialized product development on the attune femoral trial family and concluded there are no design improvements, protective measures or information for safety that would definitely reduce the risks associated with these complaints without potentially increasing/adding other risks.No further work required.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE CR FEM TRIAL SZ 8 LT
• Type of Device: KNEE INSTRUMENT/TRIAL
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5276566
• MDR Text Key: 32978853
• Report Number: 1818910-2015-36991
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2016

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: 254500718
• Device Lot Number: MVMBKD410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/21/2015; 01/11/2016; 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1