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

Catalog Number UNK ATTUNE KNEE PATELLA

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

Patient Problem Joint Laxity (4526)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient was revised due to instability.Insert and patella were revised.Doi: unknown dor: (b)(6) 2021 left knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.H10 additional narrative: added: d10.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: ATTUNE KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11841834
• MDR Text Key: 251180077
• Report Number: 1818910-2021-10558
• Device Sequence Number: 1
• Product Code: OIY
• 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,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE PATELLA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 07/01/2021
• Supplement Dates FDA Received: 06/30/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANATOMIC PATELLA SIZE UNKNOWN; ATTUNE PS RP INSRT SZ5 5MM; ATTUNE RP PS SIZE 5-5MM INSERT; ANATOMIC PATELLA SIZE UNKNOWN; ATTUNE RP PS SIZE 5-5MM INSERT
• Patient Outcome(s): Required Intervention