MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product complaint #: (b)(4).The source of the information is post market studies.There is limited information regarding the patient's death at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Associated study: registry, date of evaluation: (b)(6) 2024, date of onset: 25/jan/2024, diagnosis: death, country: us, serious: yes, device related: definitely not, procedure related: remote possibility, subject's age at enrollment: 78, subject's gender: male, subject's height: 70 in, subject's weight: 142 lbs.(b)(4) are related to each other.Both complaints are created for the bilateral knees.(b)(4) capture the left knee.(b)(4) capture the right knee.
Additional Manufacturer Narrative
Product complaint #(b)(4).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 perform.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 : 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.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
Additional information received states that the cause of death is unknown.Death is always a possibility with surgical procedures.He did not pass while hospitalized.

• Brand Name: ATTUNE CR FEM RT SZ 7 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18747645
• Report Number: 1818910-2024-03813
• Device Sequence Number: 3702933
• Product Code: JWH
• UDI-Device Identifier: 10603295041221
• UDI-Public: 10603295041221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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: 150400207
• Device Lot Number: D23092039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 03/11/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/06/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CR RT MS INS SZ 7 8; DEPUY CMW 1 40G; DEPUY CMW 1 40G
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 64 KG