MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 3 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-223
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	01/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that attune femoral right implant was opened and residue was on posterior femoral condyle.The implant was removed from surgical field and a new implant was opened.No surgical delay.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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: the product was returned to depuy synthes for evaluation.The depuy synthes team forwarded, the device to depuy orthopaedics raynham.Which, conducted a visual inspection of the returned device.On examination of the returned complaint unit revealed, that the device was returned opened and with the original packaging.Additionally, an adhesive-like foreign matter was found on the returned implant.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed, for the finished device [150400223 /150400223] number.And no non-conformances/manufacturing irregularities were identified, during manufacturing.Device history review: a manufacturing record evaluation was performed, for the finished device [150400223 /150400223] number.And no non-conformances/manufacturing irregularities were identified, during manufacturing.

• Brand Name: ATTUNE CR FEM RT SZ 3 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11477573
• Report Number: 1818910-2021-05047
• Device Sequence Number: 14583594
• Product Code: JWH
• UDI-Device Identifier: 10603295041269
• UDI-Public: 10603295041269
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2021

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: 1504-00-223
• Device Catalogue Number: 150400223
• Device Lot Number: J80H58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 07/29/2021; 04/25/2023
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/13/2021; 08/04/2021; 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown