MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.-1818910 UNKNOWN PS INSTRUMENTS; KNEE INSTRUMENT/TRIAL

Catalog Number UNK-KNEE

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Infected 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

Device is available for evaluation - (date product rec¿d by mfg.).The investigation is ongoing.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

A complaints search and dhr review did not identify any anomalies.This complaint is with regard to infected attune total knee replacements which occurred at (b)(6).Upon receiving the complaint the decision was made to make a site visit to the facility in which the cleaning and re-sterilization of the attune intuition instruments for (b)(6) hospital occurs.Depuy provided onsite training to the ssd staff and included an explanation of the symbols on the instruments, how to assemble/disassemble the devices, and a demonstration of the cleaning positions of the instruments when placed into the trays and its rationale.This was delivered to 5 groups of ssd staff (36 people).From the information received and the investigation performed the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion, and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.

• Brand Name: UNKNOWN PS INSTRUMENTS
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3897717
• MDR Text Key: 16447468
• Report Number: 1818910-2014-22088
• 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,Followup
• Report Date: 06/12/2014

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: UNK-KNEE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• 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