MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 9 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630916
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: dots clinical adverse event received for spin out.Information related to severity of event is not provided.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2024 date of event: 03 jun 2024 (right knee) treatment: awaiting further evaluation depuy products used (no revision completed): additional event information revision date: (b)(6) 2024 new information was received that indicates the patient has now undergone a revision for the instability and spin out.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary = > no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part #151630916 /lot #4141432 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 depuy nonconformance (nc) quality system found no nc¿s associated with this product part # 151630916 /lot #4141432 combination.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
Clinical update was reviewed: treatment/intervention: removal of depuy components.
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.Added: b5.Corrected: d6a.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 9 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: 20085891
• Report Number: 1818910-2024-18223
• Device Sequence Number: 12724672
• Product Code: NJL
• UDI-Device Identifier: 10603295048299
• UDI-Public: (01)10603295048299(17)280430(10)4141432
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 151630916
• Device Lot Number: 4141432
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2023
• 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 CR FEM RT SZ 9 CEM.; ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE RP TIB BASE SZ 9 CEM.; DEPUY CMW 1 40G.; DEPUY CMW 1 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White