MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-105

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

Patient Problem Joint Laxity (4526)

Event Date 04/06/2021

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

It was reported that the primary surgery was performed by another surgeon, but the patient had come to see the surgeon for instability.Surgeon said the patient was loose in extension and mid flexion and decided to revise her femoral component.After removing her femoral component he reamed for a stem and sleeve and replaced with the appropriate size.He trailed his poly for stability and replaced with a stable size.Two depuy cement was used.No loosening and no delay in surgery.Doi: (b)(6) 2019.Dor: (b)(6) 2021.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.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11699673
• MDR Text Key: 246443337
• Report Number: 1818910-2021-08378
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-105
• Device Catalogue Number: 150410105
• Device Lot Number: 9045551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ5 5MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ5 5MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR