MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATUN PRESSFIT STR STEM16X110MM; KNEE STEMS

Catalog Number	151316110
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 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 performed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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
Subject id: (b)(6), study no: (b)(6).Clinical adverse event received for loosening of components of left knee, device and procedure (relatedness): device related: possibly, procedure related: possibly, date of event: 29-jan-2025, date of implant: (b)(6) 2020, date of revision: no information provided, device location: left.Treatment/impact: no intervention/treatment at this time.Depuy synthes products used: catalog number: 150440104, lot number id: j3198u, component type: femoral component, device identifier: (b)(4).Catalog number: 151316110, lot number id: j2332w, component type: femoral stem, device identifier: (b)(4).Catalog number: 154904001, lot number id: j32a89, component type: femoral medial posterior augment, device identifier: (b)(4).Catalog number: 154904002, lot number id: j4629y, component type: femoral lateral posterior augment, device identifier: (b)(4).Catalog number: 150660004, lot number id: 9113354, component type: tibial base component, device identifier: (b)(4).Catalog number: 151214030, lot number id: j5202d, component type: tibial stem, device identifier: (b)(4).Catalog number: 151302000, lot number id: 8596354, component type: femoral stem offset adaptor, device identifier: (b)(4).Catalog number: 152303001, lot number id: j1172n, component type: tibial medial augment, device identifier: (b)(4).Catalog number: 152303001, lot number id: j3010n, component type: tibial lateral augment, device identifier: (b)(4).Catalog number: 151710422, lot number id: 8683684, component type: tibial insert component, device identifier: (b)(4).Catalog number: 61979001, lot number id: maa003, component type: cement, device identifier: (b)(4).

• Brand Name: ATUN PRESSFIT STR STEM16X110MM
• 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: 21881798
• Report Number: 1818910-2025-06111
• Device Sequence Number: 15645569
• Product Code: JWH
• UDI-Device Identifier: 10603295043676
• UDI-Public: (01)10603295043676(17)290131(10)J2332W
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 151316110
• Device Lot Number: J2332W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 84 KG