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

Catalog Number	150400208
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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
It was reported that small threads discovered inside of the femoral shield.It was discovered when the nurse opened up the box and they have not touched the product.No patient involved.
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.H10 additional narrative: 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 it was reported that small threads discovered inside of the femoral shield.It was discovered when the nurse opened up the box and they have not touched the product.No patient involved.Pictures attached.Note: the complaint device was evaluated and investigated by the manufacturing site.Please refer to the attachment (b)(4) investigation.Docx, for the investigation report.The product was returned to depuy synthes and the team conducted a visual inspection of the returned device.Based on the investigation performed, the complaint is considered localized.The complaint device was returned-however, the described defect could not be confirmed.Based on this, the root cause could not be determined.Any new complaints for this complaint type will be continued to be monitored.No further actions are required at this time.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the attune cr fem rt sz 8 cem.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product device history record or batch traveler was reviewed for batch m16c65.No manufacturing-related issues or deviations were noted.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported that small threads discovered inside of the femoral shield.It was discovered when the nurse opened up the box and they have not touched the product.No patient involved.Pictures attached.Note: the complaint device was evaluated and investigated by the manufacturing site.Please refer to the attachment (b)(4) investigation.Docx, for the investigation report.The product was returned to depuy synthes and the team conducted a visual inspection of the returned device.Based on the investigation performed, the complaint is considered localized.The complaint device was returned-however, the described defect could not be confirmed.Based on this, the root cause could not be determined.Any new complaints for this complaint type will be continued to be monitored.No further actions are required at this time.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the hardinge fem cement restr.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product device history record or batch traveler was reviewed for batch m16c65.No manufacturing-related issues or deviations were noted.

• Brand Name: ATTUNE CR FEM RT SZ 8 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17812471
• Report Number: 1818910-2023-19408
• Device Sequence Number: 7249558
• Product Code: JWH
• UDI-Device Identifier: 10603295041238
• UDI-Public: 10603295041238
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 09/25/2023

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 Catalogue Number: 150400208
• Device Lot Number: M16C85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 03/19/2024; 03/26/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/19/2023; 03/19/2024; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• 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