MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CRS RP INSRT SZ 7 16MM; KNEE TIBIAL INSERT

Catalog Number	151710716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has implants in as temporary spacer due to infected knee.The patient had knee i&d and poly exchange.Poly was removed and replaced.There was no delay and no complaints.Doi: (b)(6) 2025, dor: (b)(6) 2025, affected side: left knee.
Additional Manufacturer Narrative
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 no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed for the finished device product code:151710716, lot -4216378 and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a manufacturing record evaluation (nc search) was performed for the finished device product code:151710716, lot -4216378 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: ATTUNE CRS RP INSRT SZ 7 16MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22223092
• Report Number: 1818910-2025-09838
• Device Sequence Number: 8620167
• Product Code: NJL
• UDI-Device Identifier: 10603295056171
• UDI-Public: (01)10603295056171(17)20280630(10)4216378
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151710716
• Device Lot Number: 4216378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female