MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM18X60MM; KNEE STEMS

Catalog Number	151318060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	04/01/2026
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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported a patient received a knee prosthesis (the third one) and has had a severe inflammation in the knee since the first prosthesis.Unfortunately, this has not subsided even after very long-term antibiotic therapy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, from customer letter: thank you very much for your feedback.This concerns a patient of mine who received a knee prosthesis (the third one) implanted by you and has had a severe inflammation in the knee since the first prosthesis.Unfortunately, this has not subsided even after very long-term antibiotic therapy.I would now like to test whether a possible individual material intolerance is present and therefore require the exact specification of the alloy components, possibly also the composition of the cement, so that i can have this tested in the laboratory.You will find the implantation passport attached.I thank you very much in advance for your support.The product was not returned to depuy synthes; however, photos were provided for review.The photographs attached were reviewed, however they do not represent the reported atune pressfit str stem18x60mm.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported atune pressfit str stem18x60mm.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device product code 151318060 lot number d24073637, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Event or Problem Description
Additional information received states that devices that were implanted in (b)(6) 2025 are still implanted in the patient.

• Brand Name: ATUNE PRESSFIT STR STEM18X60MM
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25177014
• Report Number: 1818910-2026-08835
• Device Sequence Number: 10624474
• Product Code: JWH
• UDI-Device Identifier: 10603295043720
• UDI-Public: (01)10603295043720(17)340630(10)D24073637
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 151318060
• Device Lot Number: D24073637
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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 8 CEM; ATTUNE CRS RP INSRT SZ 8 6MM; ATTUNE DIST FEM AUG SZ 8 12MM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 8 CEM; COMPETITOR CEMENT (66017747/74391543)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown