MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150410204

Device Problems Incomplete or Missing Packaging (2312); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).At this time it is unknown if the sterility was breached.Additional follow up is being conducted to clarify.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

While opening the original implant (attune femoral component posterior stabilized ,size 4 right side femur) only one displaced shape of implant inner box was observed.Two inner box will be present usually.Surgeon was on doubt, whether its sterile or not.So, he did not use this implant and kept aside and used same size of another implant.Surgery was delayed 10 minutes due to the reported event.

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

Additional information was received: a.Please clarify if the sterility was breached.There is a doubt of sterility since inner product box was sticked between the boxes.

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).Investigation summary: while opening the original implant (attune femoral component posterior stabilized ,size 4 right side femur) only one displaced shape of implant inner box was observed.Two inner box will be present usually.Surgeon was on doubt, whether its sterile or not.So, he did not use this implant and kept aside and used same size of another implant.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that both blister packaging were deformed/warped.Furthermore, based on the severely warped condition of the blisters it is not unreasonable to suspect the seal between the blister and the tyvek lid was breached thus compromising the sterility of the product inside.Per a previous data review activity completed in q1 2023 related to deformed/melted blister packaging, the potential cause of the deformed/melted blister packaging, cannot be traced to manufacturing or other jnj controlled facilities through which finished goods are distributed.Once the product leaves depuy synthes control, it is unknown what environmental/external factors the finished goods products are exposed to.Therefore, the suspected cause is traced to exposer to extreme temperature conditions outside of depuy synthes control.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 4 cem contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 (nc search) was performed for the finished device product code 150410204, lot number 4259437, manufacture date 9/9/2023, expiration date 8/31/2033 and no non-conformances / manufacturing irregularities were identified.H10 additional narrative: corrected: h3.

• Brand Name: ATTUNE PS FEM RT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19087048
• MDR Text Key: 340127637
• Report Number: 1818910-2024-08078
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041757
• UDI-Public: 10603295041757
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P830055
• 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
• Report Date: 04/11/2024

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 Catalogue Number: 150410204
• Device Lot Number: 4259437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/27/2024
• Supplement Dates FDA Received: 04/24/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2023
• 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