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

Catalog Number 254500528

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

The button on the back of the articulation surface had broken off.The procedure was delayed approximately 2 minutes while we confirmed that the broken off piece was still attached to the spacer.

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.

Manufacturer Narrative

Additional narrative: the investigation remains closed, as the added information does not change the outcome of the investigation.

Manufacturer Narrative

The device associated with this report was not returned.A complaints review was completed in february 2014 and in june 2014 for all attune trial instruments, following 25,000 and 50,000 surgeries, inclusive of the attune femoral trials, articulation surface trials, and the patella trials.Previous investigations found the root cause to be attributed to user technique and/or misuse.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 sep-419.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 CR 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: 4770948
• MDR Text Key: 18290709
• Report Number: 1818910-2015-20714
• 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,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 254500528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 80