MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 16X80MM; KNEE STEMS

Catalog Number	151216080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	02/15/2020
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: d6, h4: the information provided regarding the manufacturing date and implantation date are identified to be conflicting.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for post-operative anemia.Device related: definitely not.Procedure related: definitely.Date of event: 15 feb 2020.Date of implant: (b)(6) 2020.Date of revision: no information provided.Device location: left.Treatment/impact: 2 x erythrocyte concentrate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, prt 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 hat 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: d10.Corrected: h4.If information is obtained that was not available for the initial report, 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.According to the information received, ¿clinical adverse event received¿.Quantity manufactured: (b)(4).Date of manufacture: 06/20/2018.Any anomalies or deviations identified in dhr: none.Expiry date: 05/31/2028.Ifu reference: (b)(4).A manufacturing record evaluation was performed for the finished device product description: aattune cemented stem 16x80mm product code: 151216080 lot number:hy2694 and no non-conformances were identified, however not related to the reported failure mode of the complaint.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: quantity manufactured: (b)(4).Date of manufacture: 06/20/2018.Any anomalies or deviations identified in dhr: none.Expiry date: 05/31/2028.Ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device product description: aattune cemented stem 16x80mm product code: 151216080 lot number:hy2694 and no non-conformances were identified, however not related to the reported failure mode of the complaint.

• Brand Name: ATTUNE CEMENTED STEM 16X80MM
• 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: 23368201
• Report Number: 1818910-2025-18022
• Device Sequence Number: 12990819
• Product Code: JWH
• UDI-Device Identifier: 10603295043010
• UDI-Public: (01)10603295043010(17)280501(10)HY2694
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 151216080
• Device Lot Number: HY2694
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/17/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2018
• 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 LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE MEDIAL DOME PAT 41MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR (OTIPAC 80 REFOBACIN BONE CEMENT R); COMPETITOR CEMENT (PALACOS R+G 2X20); COMPETITOR PRODUCT (TEKNIMED.); COMPETITOR(OTIPAC 60 REFOBACIN BONE CEMENT R)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown