MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-124

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

Patient Problems Adhesion(s) (1695); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, the patient underwent a second left knee revision to address pain.The surgeon noted the removal of scar tissue.The tibial insert, tibial tray, and femoral component were revised.The patellar component was retained.The surgeon noted minimal bone loss with removal of the femoral component.The patient was revised with depuy products.There were no indicated intra-operative complications.Doi: (b)(6) 2018 insert; doi: (b)(6) 2017 femoral, tibial tray; dor: (b)(6) 2019; 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.

• Brand Name: ATTUNE PS FEM LT SZ 4 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12290234
• MDR Text Key: 265490814
• Report Number: 1818910-2021-17359
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041696
• UDI-Public: 10603295041696
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-124
• Device Catalogue Number: 150410124
• Device Lot Number: 8469273
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE PS FEM LT SZ 4 NAR CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR