MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 6 4MM; KNEE FEMORAL ACCESSORY

Model Number 1547-06-001

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

Patient Problem Synovitis (2094)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Clinical adverse event received for patch of synovitis lateral aspect of left knee.Event is not serious and is considered mild.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2018; date of event: (b)(6) 2021; (left knee).Treatment: injected medication; diagnostic intervention.

Manufacturer Narrative

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

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.

• Brand Name: ATTUNE DIST FEM AUG SZ 6 4MM
• Type of Device: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15198522
• MDR Text Key: 297593027
• Report Number: 1818910-2022-15522
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295382775
• UDI-Public: 10603295382775
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1547-06-001
• Device Catalogue Number: 154706001
• Device Lot Number: HH8400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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
• Treatment: ATTUNE CRS FEMORAL LT SZ 6 CEM.; ATTUNE CRS RP INSRT SZ 6 8MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATUN FEM SLV M/L 30MM HALF POR.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM10X60MM.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 6 CEM.; SMARTSET GHV GENTAMICIN 40G.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG