MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-110

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 05/06/2020

Event Type  malfunction  

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 there was what appears to be styrofoam from the packaging adhered to the sz 10 attune ps left femoral component.The surgeon requested another implant.Some of the debris wiped off of the component but there is still residual.The component will be returned.There was a surgical delay of 1 min.Doe: (b)(6) 2020; left knee.

Manufacturer Narrative

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.Patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.A definitive root cause could not be determined and the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM LT SZ 10 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10073478
• MDR Text Key: 191536564
• Report Number: 1818910-2020-12327
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041672
• UDI-Public: 10603295041672
• 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
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-10-110
• Device Catalogue Number: 150410110
• Device Lot Number: 403302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 10 CEM; ATTUNE PS FEM LT SZ 10 CEM
• Patient Age: 67 YR
• Patient Weight: 102