MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CRS FEMORAL LT SZ 5 CEM; KNEE FEMORAL

Catalog Number 150440105

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6).Clinical adverse event received for intraoperative complication of femoral bone fracture.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Treatment includes open reduction internal fixation.Doi: (b)(6) 2018; doe: (b)(6) 2018; (left knee).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 5 CEM
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7702924
• MDR Text Key: 114441447
• Report Number: 1818910-2018-64810
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042181
• UDI-Public: 10603295042181
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150440105
• Device Lot Number: HD9059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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 Weight: 74