MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640405

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

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 Description

It was reported that expired implant has been implanted-expired date (b)(6) 2023 left total knee prosthesis.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown, patient status/outcome/ consequences, no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study no.(b)(4).Device property of none.Device in possession of none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

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: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicates that the event does not have an impact on the patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "an expired implant has been implanted." the product was not returned to depuy synthes, nor photographs were provided, however based on the event description, device and other information provided, the reported allegation can be confirmed.A manufacturing record evaluation was performed for the finished device product code :151640405 lot number : hy8124, and no non-conformances / manufacturing irregularities were identified.Manufactured date - 6/26/2018, expiration date - 31 may 2023, distribution date - (b)(6) 2022, implantation date - (b)(6) 2023.The overall complaint was not confirmed as the attune ps fb insrt sz 4 5mm would not contribute to the reported allegation.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is required.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 product code :151640405 lot number : hy8124, and no non-conformances / manufacturing irregularities were identified.

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.

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: added: b5, h6 (medical device problem code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received and it was stated that the root cause of the issue is related to a human error.The implant should have been extracted from his arsenal and, during the pose, the medical staff in the operating room should have checked that the implant had expired before it was implanted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "an expired implant has been implanted.".The product was not returned to depuy synthes, nor photographs were provided, however based on the event description, device and other information provided, the reported allegation can be confirmed.A manufacturing record evaluation was performed for the finished device product code :151640405 lot number : hy8124, and no non-conformances / manufacturing.Irregularities were identified.Manufactured date - 6/26/2018.Expiration date - 31 may 2023.Distribution date - 22 sep 2022.Implantation date - (b)(6) 2023.The overall complaint was confirmed as the attune ps fb insrt sz 4 5mm would contribute to the reported allegation.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is required.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 product code :151640405 lot number : hy8124, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: ATTUNE PS FB INSRT SZ 4 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17835791
• MDR Text Key: 324500689
• Report Number: 1818910-2023-19689
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049784
• UDI-Public: 10603295049784
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 151640405
• Device Lot Number: HY8124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 11/10/2023; 11/17/2023; 12/01/2023; 01/05/2024; 01/16/2024
• Supplement Dates FDA Received: 10/02/2023; 11/13/2023; 11/30/2023; 12/04/2023; 01/09/2024; 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1