MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE FB PS ARTIC SURF SZ8; KNEE INSTRUMENT/TRIAL

Catalog Number 254500508

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/13/2015

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).The device associated with this report was not returned.The initial report stated the device would not be 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 investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the inability to identify root cause, the need for corrective action was not indicated.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.

Event Description

One of the two plastic posts broke off the insert trial.

Manufacturer Narrative

Examination of the returned device confirms the reported event of tiral breagage.The smaller post of the trial is sheared off and was not 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 FB PS ARTIC SURF SZ8
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5038270
• MDR Text Key: 24359205
• Report Number: 1818910-2015-29215
• 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

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: 254500508
• Device Lot Number: MVMBSW020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 100