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 09/14/2015

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Size 8 left attune trial femur was not seated all the way before doctor out leg into extension causing trial femur to break into two pieces.

Manufacturer Narrative

Examination of the returned device confirms the reported event of trial breakage.The root cause is attributed to user technique and/or misuse as the initial report stated the trial was not fully seating prior to range of motion testing causing the reported breakage.(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. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5104165
• MDR Text Key: 26759209
• Report Number: 1818910-2015-31456
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• 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: MVMBGZ060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2013
• 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
• Patient Age: 63 YR