MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CRS RP INSRT SZ 7 26MM; KNEE TIBIAL INSERT

Catalog Number	151710726
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(6).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6) study no: dots clinical adverse event received for revision due to infection device related: no information provided procedure related: no information provided date of event: september 6, 2024 date of implant: (b)(6) 2024 date of revision: (b)(6) 2024 device location: left.Treatment/impact: blood thinners (other/unspecified) and ted hose.
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary no device associated with this report was received for examination.Product description- attune crs rp insrt sz 7 26mm product code- 151710726 lot no- 3943579 quantity of manufactured- (b)(4) date of manufacturing- 21-oct-2022 expiry date- 30-sep-2027.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 product description- attune crs rp insrt sz 7 26mm product code- 151710726 lot no- 3943579 quantity of manufactured- (b)(4) date of manufacturing- 21-oct-2022 expiry date- 30-sep-2027.Device history review a manufacturing record evaluation was performed for the finished device [lot: 3943579], and no non-conformances / manufacturing irregularities were identified.Added: b5.
Event or Problem Description
Additional information was received: clinical adverse event received for revision due to infection, device related: no information provided, procedure related: no information provided, date of event: september 6, 2024, date of implant: (b)(6) 2024, date of revision: (b)(6) 2024, device location: left.

• Brand Name: ATTUNE CRS RP INSRT SZ 7 26MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20417324
• Report Number: 1818910-2024-21278
• Device Sequence Number: 15506291
• Product Code: NJL
• UDI-Device Identifier: 10603295056225
• UDI-Public: (01)10603295056225(17)270930(10)3943579
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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: 151710726
• Device Lot Number: 3943579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 81 KG