MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE CONV FB PS TB TRL SZ8; KNEE INSTRUMENTS

Catalog Number 254500978

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/19/2015

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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

The post on the bottom of the insert sheared off.

Manufacturer Narrative

(b)(4).Examination of the returned device confirms the reported event of trial breakage.The fractured post/balseal was returned for evaluation.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following (b)(4), inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Findings of the complaints review prompted dfmea updates where applicable.The root cause is attributed to user technique and/or misuse.The damage suggests the trial was pryed or otherwise inappropriately removed during trialing.Based on the root cause of suspected misuse, corrective action is not needed.Monitor subsequent reports 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 CONV FB PS TB TRL SZ8
• Type of Device: KNEE INSTRUMENTS
• 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: 5024655
• MDR Text Key: 23824973
• Report Number: 1818910-2015-28779
• Device Sequence Number: 1
• Product Code: LXH
• 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: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500978
• Device Lot Number: BFAOHYP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2012
• 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 Outcome(s): Other