MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CR FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620506
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
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 narrative: e1: reporter is a legal professional.
Event or Problem Description
On (b)(6) 2016, the patient had a left total knee arthroplasty to address degenerative joint disease.Depuy components, including depuy patella and depuy cement were implanted during this procedure.On (b)(6) 2025, the patient had a left total revision to address loosening of the tibial component with debonding of the cement, medical polyethylene wear with some osteolysis, mild mid flexion instability with external rotation of the femoral component.The indications for surgery include pain.Doi: (b)(6) 2016, dor: (b)(6) 2025, affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- attune cr fb insrt sz 5 6mm product code:- 151620506 lot no:- 581402 quantity of manufactured:- (b)(4) date of manufacturing:- oct-2014 expiry date:- sep-2019 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 cr fb insrt sz 5 6mm product code:- 151620506 lot no:- 581402 quantity of manufactured:- (b)(4) date of manufacturing:- oct-2014 expiry date:- sep-2019 device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.H11 additional narrative: added: d10.

• Brand Name: ATTUNE CR FB INSRT SZ 5 6MM
• Common Device Name: ATTUNE IMPLANT : 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22440776
• Report Number: 1818910-2025-11615
• Device Sequence Number: 4745809
• Product Code: JWH
• UDI-Device Identifier: 10603295045656
• UDI-Public: (01)10603295045656(17)20190930(10)581402
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 151620506
• Device Lot Number: 581402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2014
• 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 CR FEM LT SZ 5 CEM.; ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 32MM.; SMARTSET GMV 40G US EO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female