MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151810038

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem Fall (1848)

Event Date 12/06/2017

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

The patient was revised to address instability of knee joint and loosening of the patella at the cement to implant interface, cement manufacturer is competitor.It also stated that a thicker implant is needed for stability, and fractured patella probably from falling event.Doi: (b)(6) 2016; dor: (b)(6) 2017; right knee.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: product code 151810038, lot number 8325797.Device history review: product code 15180038, work order (b)(4) was manufactured on 01 july 2016.30 parts were manufactured per specification and all raw materials met specification.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ATTUNE MEDIAL ANAT PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7163407
• MDR Text Key: 96332005
• Report Number: 1818910-2018-50134
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056645
• UDI-Public: 10603295056645
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151810038
• Device Lot Number: 8325797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Date Device Manufactured: 07/01/2016
• 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: 60 YR
• Patient Weight: 88