MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150410105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 07/23/2019

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

Clinical adverse event received for medial epicondyle fracture : bone fracture - femoral - valgus knee with osteopenic medial bone.Event is serious and is considered moderate.There is a remote possibility event is related to device and definitely is related to procedure.Date of implantation: (b)(6) 2019; date of event (onset): (b)(6) 2019, (left knee).

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

As per event description there is no surgical intervention happened.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8922381
• MDR Text Key: 155258841
• Report Number: 1818910-2019-102032
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150410105
• Device Lot Number: 9095501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS/RP INSERT SZ 5 12MM; ATTUNE ROTATING PLATFORM TIBIAL BASE SIZE 5; ATTUNE PS/RP INSERT SZ 5 12MM; ATTUNE ROTATING PLATFORM TIBIAL BASE SIZE 5
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100