MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM NAR POR CR LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150401126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of attune knee replacement, change of poly 5mm to 12mm.Fracture found distal femur.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> yes, did the patient require revision surgery or hardware removal? --> yes, facility name of original implant --> [hospital] , was device explanted? --> true, hardware/explant removal due to: --> pain, did patient require revision surgery? --> true, if yes, date of revision surgery.--> [date], reason for revision surgery.--> pain, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?--> xray and bone scan , patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> pain and fracture, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> yes, if yes, describe --> xray bone scan , is the patient part of a clinical study --> no, ip-01911960 device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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
Additional information was received and stated that the affected site was the left side.The fractured part was the femoral bone.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed.  if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE FEM NAR POR CR LT SZ 6
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18325565
• Report Number: 1818910-2023-25350
• Device Sequence Number: 7359037
• Product Code: MBH
• UDI-Device Identifier: 10603295041436
• UDI-Public: 10603295041436
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023
• 2 Devices were Involved in the Event: 1 2

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: 150401126
• Device Lot Number: 4203227
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 01/05/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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 RP INSRT SZ 6 5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female