MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE CR FEM TRIAL SZ 5 RT; KNEE INSTRUMENT/TRIAL

Catalog Number 254500705

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).For product information received.Depuy synthes has been informed that the lot number is not available.

Event Description

Surgeon elected to implant attune trials as a spacer until the infection is eradicated.

Manufacturer Narrative

The devices associated with this report were not returned and are presumed yet implanted.The complainant reported during a revision surgery all the attune devices were removed.Surgeon elected to insert attune trial instruments as spacers until the infection was eradicated.The use of the attune trial instruments as spacers is not recommended by depuy.Trial components are not designed to be left in the patient.The material of the attune trial instruments are is not implant grade material.The root cause is attributed to user error.The investigation did not find any evidence of product error as a contributing factor to the reported event and the need for corrective action is not indicated.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 CR FEM TRIAL SZ 5 RT
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6254478
• MDR Text Key: 64886285
• Report Number: 1818910-2017-10983
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 254500705
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 39 YR