MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-510

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

Patient Problems Wound Dehiscence (1154); Pain (1994)

Event Date 08/30/2021

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

The patient was revised for pain.I and d was performed.Doi: (b)(6) 2021, dor: (b)(6) 2021, (left knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Questions: a.What was the reason for i&d? was there an infection? b.Was the patient experiencing any adverse symptoms that will lead to the revision surgery?" answer: "wound dehiscence, no other information available".

• Brand Name: ATTUNE PS FB INSRT SZ 5 10MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12527310
• MDR Text Key: 273163737
• Report Number: 1818910-2021-21061
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295049968
• UDI-Public: 10603295049968
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1516-40-510
• Device Catalogue Number: 151640510
• Device Lot Number: J74H91
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention