MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM10X60MM; KNEE STEMS

Model Number	1513-10-060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
(b)(6).Clinical adverse event received for superficial wound infection.Event is serious and is considered severe.There is a remote possibility that the event is possibly related to device and is definitely related to procedure.Date of implantation: (b)(6) 2021.Date of event (onset): (b)(6) 2021.(right knee) treatment: injected medication (unspecified), oral medication (unspecified).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.
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 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, d3.Corrected: h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for superficial infection, device and procedure (relatedness), device related: definitely not, procedure related: definitely, date of event: 05 may 2021, date of implant: (b)(6) 2021, date of revision: no information provided.Device location: right, treatment/impact: hospitalization (initial or prolonged): yes, readmitted to hospital: yes, injected medication: yes, oral medication: yes.

• Brand Name: ATUNE PRESSFIT STR STEM10X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 12041402
• Report Number: 1818910-2021-13254
• Device Sequence Number: 14453147
• Product Code: JWH
• UDI-Device Identifier: 10603295043485
• UDI-Public: 10603295043485
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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 Model Number: 1513-10-060
• Device Catalogue Number: 151310060
• Device Lot Number: J8465P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 10/07/2025
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/02/2021; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; COMPETITOR BONE CEMENT (ZIMMER); COMPETITOR BONE CEMENT (ZIMMER); ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; COMPETITOR BONE CEMENT (ZIMMER); COMPETITOR BONE CEMENT (ZIMMER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 103 KG