MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 5 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630505
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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).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 or Problem Description
It was reported that the patient underwent the surgery via tka with the implant in question.The implant in question was removed due to infection.On (b)(6) 2024, the surgeon noted that the implant in question, which had been extracted in the past, was yellowish.It was also noted that the implant in question may have been oxidized.No further information is available.Doi: (b)(6) 2022 doe: (b)(6) 2023.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > according to the information received, "it was reported that on an unknown date, the patient underwent the surgery via tka with the implant in question.On an unknown date, the implant in question was removed due to infection.On feb 6, 2024, the surgeon noted that the implant in question, which had been extracted in the past, was yellowish.It was also noted that the implant in question may have been oxidized.Details such as the implant (insert) used, and the date of removal surgery are unknown.A sales representative will confirm the details at a later date.No further information is available".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that attune cr rp insrt sz 5 5mm exhibits yellowish discoloration.Discoloration could be the result of patient lipids staining, oxidation, or combination of other contributing factors.Additionally, the bottom surface of the liner presents sings of pitting and circular scratches, consistent with a third body debris becoming trapped between the articulating surfaces of the tibial base and insert.No other defects were observed.With the information provided is not possible to determine a potential cause at this moment for the observed pitting and scratches.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [151630505 / 3788068] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The sterility certificate of irradiation was review for the reported finished device and met specification.The overall complaint was confirmed as the observed condition of the attune cr rp insrt sz 5 5mm would contribute to a device issue.Based on the investigation findings, 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 was performed for the finished device [151630505 / 3788068] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The sterility certificate of irradiation was review for the reported finished device [151630505 / 3788068] and met specification.H3.

• Brand Name: ATTUNE CR RP INSRT SZ 5 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: 18712392
• Report Number: 1818910-2024-03403
• Device Sequence Number: 12576717
• Product Code: NJL
• UDI-Device Identifier: 10603295047742
• UDI-Public: 10603295047742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151630505
• Device Lot Number: 3788068
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 04/01/2024; 05/03/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/08/2024; 04/02/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE RP TIB BASE SZ 5 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown