MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA

Catalog Number UNK ATTUNE KNEE PATELLA

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 11/13/2019

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

The patient was revised due to patella maltracking.The doctor didn't put enough external rotation on the femur during the revision and are going back in to correct this problem so the patella tracks better.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Left knee.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: corrected: h6 (device) product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: UNK ATTUNE KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9429671
• MDR Text Key: 169642938
• Report Number: 1818910-2019-121492
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE PATELLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS RP INSRT SZ 9 10MM.; ATTUNE POS FEM AUG SZ 9 12MM.; ATTUNE POS FEM AUG SZ 9 8MM.; ATUN FEM SLV M/L 35MM FULL POR.; ATUNE PRESSFIT STR STEM18X60MM.; ATTUNE CRS RP INSRT SZ 9 10MM; ATTUNE POS FEM AUG SZ 9 12MM; ATTUNE POS FEM AUG SZ 9 8MM; ATUN FEM SLV M/L 35MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 111