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

Model Number	1504-00-104
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Knee surgery/ktep: preparation was finished, implants taken out of boxes.On femur-component traces of adhesive were found.This implant was rejected.Another one was implanted.No surgery delay.Procedure successfully completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The event is considered an isolated incident and the need for corrective action is not indicated.Depuy synthes 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: review of the associated dhr did not uncover any manufacturing related issues or non-conformances.A non-conformance search was performed for the foam lot issued and no non-conformances were found.Corrected: h3.

• Brand Name: ATTUNE CR FEM LT SZ 4 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11841643
• Report Number: 1818910-2021-10546
• Device Sequence Number: 2911032
• Product Code: NJL
• UDI-Device Identifier: 10603295041054
• UDI-Public: 10603295041054
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-00-104
• Device Catalogue Number: 150400104
• Device Lot Number: J89M33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 05/24/2021; 07/14/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/26/2021; 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1