MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150410107

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address quad tendon rupture.Revised poly and did an i&d.Tendon was repaired.No infection suspected.Doi: (b)(6) 2018; dor: (b)(6) 2018; left 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.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 PS FEM LT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8240751
• MDR Text Key: 132828161
• Report Number: 1818910-2019-80670
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041641
• UDI-Public: 10603295041641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150410107
• Device Lot Number: 8827307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 132