MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820038

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Fall (1848); Scar Tissue (2060)

Event Date 06/26/2018

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

It was reported that the patient received a depuy attune total knee in 2015.Patient subsequently had multiple revisions of his knee to address a variety of issues.Most recently patient fell on his left patella possibly disrupted the patella tracking.The surgeon elected to open the left knee to determine the extent of damage.It was determined that a lateral release, scar tissue removal and exchange of the existing patella component to a smaller size would benefit the patient and implanted.The smaller dimensions of this device helped to debulk the overall thickness of the pre-existing component.The patella was now tracking more central in the femoral sulcus, surgeon believes that this procedure has rectified the patient current issues.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was 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.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 DOME PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7721724
• MDR Text Key: 115066289
• Report Number: 1818910-2018-65229
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056690
• UDI-Public: 10603295056690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103756
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151820038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR