MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.-1818910 ATTUNE QKIT PINNING SYSTEM; KNEE INSTRUMENT/TRIAL

Catalog Number 254400111

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Infected attune tkr.Patient knee became infected following attune tkr.

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.

Manufacturer Narrative

The investigation identified no issues which may have contributed to the reported incident.The complaint shall be closed with an undetermined conclusion; it shall be entered onto the complaints database and monitored through trend analysis.Should further information be provided, then the complaint shall be investigated further.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE QKIT PINNING SYSTEM
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.-1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.-1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3897472
• MDR Text Key: 4545992
• Report Number: 1818910-2014-22107
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 254400111
• Device Lot Number: 421933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR