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 Code	Unspecified Infection (1930)
Date of Event	12/02/2024
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: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 patient presented with infection and dr.Decided to remove all existing implants and put in a temporary spacer until infection has cleared.It was unknown, if there was a surgical delay.Doi- (b)(6) 2024.Dor- (b)(6) 2024.Affected side- right knee.
Event or Problem Description
Additional information was received and states that: no surgical delay.
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 that 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: b5.If information that was not available for the initial report is obtained, 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.A search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<151318060>/lot combination.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 a search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<151318060>/lot combination.H11 additional narrative: added: d4 (expiry date), d10 (concomitant), h4 corrected: d4 (primary udi number).

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20940875
• Report Number: 1818910-2024-25438
• Device Sequence Number: 4514001
• Product Code: JWH
• UDI-Device Identifier: 10603295043720
• UDI-Public: (01)10603295043720(17)340430(10)D24051181
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151318060
• Device Lot Number: D24051181
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 01/09/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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 MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 10MM; ATUN TIB SLV M/L 45MM HALF POR; ATUNE REV RP TIB BASE SZ 7 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male