MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 8 CEM; ATTUNE FEMORAL

Model Number	1504-00-108
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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 intraoperatively during primary knee-tep left side the femoral component was opened and found to be scratched on the surface.Another implant was available and used.No surgical delay, no adverse patient consequences.
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 cannot confirm the reported allegation.The device was sent to depuy orthopaedics raynham manufacturing site who identified that the visual cosmetic defect was a polymer-like residue and not indentation on the part.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.Device history lot: a manufacturing investigation evaluation was performed for the finished device 150400108 attune cr fem lt sz 8 cem j77n89, and no manufacturing irregularities were identified.1) quantity manufactured: (b)(4).2) date of manufacture: 3/27/2020.3) any anomalies or deviations identified in dhr: na.4) expiry date: 4/30/2030.5) ifu reference: (b)(4).Device history review: a manufacturing investigation evaluation was performed for the finished device 150400108 attune cr fem lt sz 8 cem j77n89, and no manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device cannot confirm the reported allegation.The device was sent to depuy orthopaedics raynham manufacturing site who identified that the visual cosmetic defect was a polymer-like residue and not indentation on the part.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.Device history lot: a manufacturing investigation evaluation was performed for the finished device 150400108 attune cr fem lt sz 8 cem j77n89, and no manufacturing irregularities were identified.Quantity manufactured: 12.Date of manufacture: 3/27/2020.Any anomalies or deviations identified in dhr: na.Expiry date: 4/30/2030 ifu reference: (b)(4).Device history review: a manufacturing investigation evaluation was performed for the finished device 150400108 attune cr fem lt sz 8 cem j77n89, and no manufacturing irregularities were identified.

• Brand Name: ATTUNE CR FEM LT SZ 8 CEM
• Common Device Name: ATTUNE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12696952
• Report Number: 1818910-2021-23497
• Device Sequence Number: 3991222
• Product Code: JWH
• UDI-Device Identifier: 10603295041092
• UDI-Public: 10603295041092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2021

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: 1504-00-108
• Device Catalogue Number: 150400108
• Device Lot Number: J77N89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 07/27/2022; 06/22/2023
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/10/2021; 07/28/2022; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown