MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM14X110MM; KNEE STEMS

Catalog Number	151314110
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Fibrosis (3167)
Date of Event	12/16/2025
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.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 the patient underwent the revision of an attune due to loose femoral and tibial components.The surgeon noted fibrous tissue up the femoral canal around the femoral stem causing loosening.The tibial component was loose as it appeared that the surgeon had cemented in the cementless tibial sleeve.Resulting in no bone ingrowth.The patella component was retained from previous primary tkr.The loosening was between the implant and bone interfaces.Affected side: right side.
Event or Problem Description
Additional information received states that loosening between the implant and bone interfaces.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.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- the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: b5, d10 (concomitant), h6 (health effect - clinical code).Corrected: d4 (primary udi number, expiry date), h4, h6 (medical device problem code).Updated pec code from implant loosening interface - unknown to implant loosening interface - implant to bone, and patient code inadequate osteointegration.

• Brand Name: ATUN PRESSFIT STR STEM14X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 23958190
• Report Number: 1818910-2026-00065
• Device Sequence Number: 5610330
• Product Code: JWH
• UDI-Device Identifier: 10603295043614
• UDI-Public: (01)10603295043614(17)280101(10)HN9865
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151314110
• Device Lot Number: HN9865
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2021
• 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 CRS FEMORAL RT SZ 5 CEM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATTUNE PS RP INSRT SZ 5 8MM.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM12X60MM.; ATUNE REV RP TIB BASE SZ 4 CEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female