MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATUN PRESSFIT STR STEM12X110MM; KNEE STEMS

Catalog Number	151312110
Medical Device Problem Codes	Loss of or Failure to Bond (1068); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2006
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for revision ¿ aseptic loosening.Device and procedure (relatedness).Device related: no information provided.Procedure related: no information provided.Date of event: 26 jan 2026.Date of implant: (b)(6) 2008.Date of revision: (b)(6)2026.Device location: left.Treatment/impact: knee replacement; were depuy synthes components removed? yes, components removed (femoral, insert, tibial.Depuy synthes products used: catalog number: 150440108.Lot number: mc4462.Component type: femoral.Description: attune revision crs femoral size 8 left cemented.Catalog number: 150660006.Lot number: 4986915.Component type: tibial.Description: attune revision tibial base rotating platform size 6 cemented.Catalog number: 151710810.Lot number: 9927060.Component type: insert.Description: attune revision crs rotating platform insert size 8 10mm.Catalog number: 151214050.Lot number: d25093258.Component type: stem.Description: attune revision cemented stem 14 mm x 50 mm.Catalog number: 545050501.Lot number: 4989849.Component type: cement.Description: smartset cement with gentamicin 40g.Catalog number: 151111203.Lot number: mc6963.Component type: sleeve.Description: attune revision tibial sleeve porocoat fully coated 45 mm.Catalog number: 151312110.Lot number: m5113p.Component type: stem.Description: attune revision pressfit stem 12 mm x 110 mm.Catalog number: 129419.Lot number: 25fsm0034.Component type: restrictor.Description: cement restrictor 25mm.
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 hat 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).Corrected: h6 (health effect - clinical code, health effect - impact code, medical device problem code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATUN PRESSFIT STR STEM12X110MM
• Common Device Name: KNEE STEMS
• 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: 24430881
• Report Number: 1818910-2026-03591
• Device Sequence Number: 10392724
• Product Code: JWH
• UDI-Device Identifier: 10603295043553
• UDI-Public: (01)10603295043553(17)331031(10)M5113P
• 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: 2008
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151312110
• Device Lot Number: M5113P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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 CEMENTED STEM 14X50MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 10MM; ATUN TIB SLV M/L 45MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM; COMPETITOR PRODUCT; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 93 KG