MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE MEDIAL DOME PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number	151820032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/27/2024
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 (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.Additional narrative: e3 initial reporter occupation: lawyer.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
It was reported that on (b)(6) 2017, the patient received a primary left knee attune tka to treat osteoarthritis.The patella was resurfaced and competitor cement x2 was utilized.The procedure was completed without complications.On (b)(6) 2024, the patient received a left knee revision to treat loosening of the tibial tray.Upon entering the joint, the tibial tray was confirmed to be loosened and debonded at the cement to implant interface.Tibial bone osteolysis was curetted.There was no reported product problem with the revised tibial insert.The femoral component was well-fixed but revised to accommodate the revision construct.The patella was well fixed and retained.The patient received an attune revision construct.The procedure was completed without complications.Doi: (b)(6) 2017.Dor: (b)(6) 2024.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.According to the information received, "on (b)(6) 2017, the patient received a primary left knee attune tka to treat osteoarthritis.The patella was resurfaced and competitor cement x2 was utilized.The procedure was completed without complications.On (b)(6) 2024, the patient received a left knee revision to treat loosening of the tibial tray.Upon entering the joint, the tibial tray was confirmed to be loosened and debonded at the cement to implant interface.Tibial bone osteolysis was curetted.There was no reported product problem with the revised tibial insert.The femoral component was well-fixed but revised to accommodate the revision construct.The patella was well fixed and retained.The patient received an attune revision construct.The procedure was completed without complications.Doi: (b)(6) 2017.Dor: (b)(6) 2024.Affected side: left knee".Product description:- attune medial dome pat 32mm.Product code:- 151820032.Lot no:- 7825590.Quantity of manufactured:- (b)(4).Date of manufacturing:- 07-jan-2014.Expiry date:- 31-dec-2018.A manufacturing record evaluation was performed for the finished device product description: attune medial dome pat 32mm, product code:151820032, lot no: 7825590 , and one non-conformance was identified, however not related to the reported failure mode of the complaint.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 07-jan-2014 3) any anomalies or deviations identified in dhr: one non-conformance was identified, however not related to the reported failure mode of the complaint.4) expiry date: 31-dec-2018.Device history review: a manufacturing record evaluation was performed for the finished device product description: attune medial dome pat 32mm, product code:151820032, lot no: 7825590 , and one non-conformance was identified, however not related to the reported failure mode of the complaint.Added: d10 concomitant.

• Brand Name: ATTUNE MEDIAL DOME PAT 32MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24484502
• Report Number: 1818910-2026-03881
• Device Sequence Number: 21492206
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 Expiration Date: 12/31/2018
• Device Catalogue Number: 151820032
• Device Lot Number: 7825590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2014
• 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 FB TIB BASE SZ 1 CEM.; ATTUNE PS FB INSRT SZ 2 5MM.; ATTUNE PS FEM LT SZ 2 CEM.; HV CEMENT (COMPETITOR).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female