MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151620708

Device Problem Expiration Date Error (2528)

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

Event Date 09/25/2023

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

The (b)(6) 2023 the hospital has implanted a product with a expiration date the 31 jul 2023 was surgery delayed due to the reported event?: unknown, was procedure successfully completed?: unknown, were fragments generated?: unknown, if yes, were they removed easily without additional intervention?: unknown, patient status/ outcome / consequences: , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (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).Investigation summary according to the information received, "the 25/9/23 th hospital has implanted a product with a expiration date the 31/7/23" 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 lot number: j0327c, product code: 151620708 and no non-conformances / manufacturing irregularities related to the malfunction were identified.No distribution date was received after performing additional follow-up   the overall complaint was confirmed as the attune cr fb insrt sz 7 8mm would contribute to the reported allegation.  based on the investigation findings, 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 lot number: j0327c, product code: 151620708 and no non-conformances / manufacturing irregularities related to the malfunction 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.

Event Description

An e-mail was received stating the following: i inform you that there is no health risk for the patient since finally the expired insert (b)(4) was not implanted.The surgeon decided to change the size of the insert once we had already opened the insert (b)(4) and finally, one more size was implanted (b)(4).Attached copy of the part of the surgery where the expense of the 2 inserts is shown (b)(4), as well as a copy of the surgery report where the surgeon justifies the reason for the insert change.

• Brand Name: ATTUNE CR FB INSRT SZ 7 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17906898
• MDR Text Key: 325308095
• Report Number: 1818910-2023-20587
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295045915
• UDI-Public: 10603295045915
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• 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
• Report Date: 10/10/2023

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: 07/31/2023
• Device Catalogue Number: 151620708
• Device Lot Number: J0327C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 12/22/2023; 02/01/2024
• Supplement Dates FDA Received: 12/11/2023; 12/26/2023; 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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