MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY

Catalog Number	150660008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: dsj-2016-02 clinical adverse event received for flexion deficit at right knee.Event is serious and is considered moderate.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2019 date of event: unk (b)(6) 2023 (right knee) treatment: diagnostic intervention and resection of heterotopic bone.
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.
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).Investigation summary: no device associated with this report was received for examination.Product description: atune rev rp tib base sz 8 cem.Product code: 150660008.Lot no: 9009609.Quantity of manufactured: (b)(4).Date of manufacturing: 12-jan-2019.Expiry date: 31-dec-2028.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 review: a manufacturing record evaluation was performed for the finished device, and no non-conformances/manufacturing irregularities were identified.

• Brand Name: ATUNE REV RP TIB BASE SZ 8 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19117311
• Report Number: 1818910-2024-08399
• Device Sequence Number: 12651946
• Product Code: NJL
• UDI-Device Identifier: 10603295042921
• UDI-Public: 10603295042921
• 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: 2019
• 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): 04/16/2024

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: 150660008
• Device Lot Number: 9009609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 06/03/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/28/2024; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2019
• 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 10MM.; ATTUNE DIST FEM AUG SZ 8 8MM.; ATTUNE DIST FEM AUG SZ 8 8MM.; ATTUNE MEDIAL DOME PAT 41MM.; ATUN FEM SLV M/L 45MM HALF POR.; ATUN TIB SLV M/L 61MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM22X60MM.; COMPETITOR CEMENT BIOMET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 154 KG