MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE PS FEM LT SZ 8 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410108
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Anxiety (2328); Distress (2329); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received a left attune tka for unknown reasons.Depuy cement x1 was utilized and the patella was resurfaced.The procedure was completed without complications.Patient received a left knee revision to treat pain, walking difficulty, joint instability, audible popping sounds, emotional distress, and anxiety.Upon entering the joint, scar tissue was debrided.The surgeon identified a loosened tibial tray at the depuy cement to implant interface, which was revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision construct.The procedure was completed without complications.Doi: (b)(6) 2023.Dor: (b)(6) 2024.Left knee.
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 medwatch, a follow-up medwatch 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.H11 additional narrative: added: d10 concomitant.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.According to the information received, "patient received a left attune tka for unknown reasons.Depuy cement x1 was utilized and the patella was resurfaced.The procedure was completed without complications.55-year-old male patient received a left knee revision to treat pain, walking difficulty, joint instability, audible popping sounds, emotional distress, and anxiety.Upon entering the joint, scar tissue was debrided.The surgeon identified a loosened tibial tray at the depuy cement to implant interface, which was revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision construct.The procedure was completed without complications.A manufacturing record evaluation was performed 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: 1) quantity manufactured: (b)(4).2) any anomalies or deviations identified in dhr: none.Device history review: a manufacturing record evaluation was performed and no non-conformances / manufacturing irregularities were identified.
Event or Problem Description
Additional information was received stated: dor: (b)(6) 2024: 55-year-old male patient received a left knee revision to treat pain and instability of the joint secondary to loosening of the tibial tray, as identified via preoperative radiographs.Upon entering the joint, the surgeon confirmed the joint instability and debrided scar tissue.The tibial trat was grossly loose at an unknown interface and revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed but retained.The patient received a competitor revision construct.The procedure was completed without complications.Doi: (b)(6) 2026.Dor: (b)(6) 2024.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, "patient received a left attune tka for unknown reasons.Depuy cement x1 was utilized and the patella was resurfaced.The procedure was completed without complications.55-year-old male patient received a left knee revision to treat pain, walking difficulty, joint instability, audible popping sounds, emotional distress, and anxiety.Upon entering the joint, scar tissue was debrided.The surgeon identified a loosened tibial tray at the depuy cement to implant interface, which was revised.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient received a competitor revision construct.The procedure was completed without complications.Doi: (b)(6) 2023.Dor: (b)(6) 2024.Left knee." product description: attune ps fem lt sz 8 cem.Product code: 150410108.Lot no: m30d40.Quantity of manufactured: (b)(4).Date of manufacturing: 25-apr-2023.Expiry date: 31-mar-2033.Ifu reference: (b)(4).A manufacturing record evaluation was performed for the finished device product description: attune ps fem lt sz 8 cem, product code: 150410108, lot no: m30d40 , 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 25-apr-2023.3) any anomalies or deviations identified in dhr: none.4) expiry date: 31-mar-2033.5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device product description: attune ps fem lt sz 8 cem, product code: 150410108, lot no: m30d40 , and no non-conformances / manufacturing irregularities were identified.Added: b5.

• Brand Name: ATTUNE PS FEM LT SZ 8 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24744620
• Report Number: 1818910-2026-05532
• Device Sequence Number: 21009470
• Product Code: JWH
• UDI-Device Identifier: 10603295041658
• UDI-Public: (01)10603295041658(17)330331(10)M30D40
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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 Catalogue Number: 150410108
• Device Lot Number: M30D40
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/04/2026; 04/17/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/29/2026; 05/05/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male