MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient felt instability with knee.Surgeon revised with a different insert option.Felt stable on table.Patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? knee instability, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.If yes, describe: knee instability is the patient part of a clinical study: unknown.(b)(4) 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).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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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.Additional narrative: 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 states that there were no surgical delays or allegations against the attune shim sz3 8mm.There was also no instability related to polyethylene wear and no reported malposition of components that led to instability.It also states that there were no undersized components on the primary surgery and primary resections were not excessive and to normal limits.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient felt instability with knee.Surgeon revised with a different insert option.Felt stable on table.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo/x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the attune ps rp insrt sz4 6mm would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 PS RP INSRT SZ4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: 18359949
• Report Number: 1818910-2023-25640
• Device Sequence Number: 12705474
• Product Code: NJL
• UDI-Device Identifier: 10603295052296
• UDI-Public: 10603295052296
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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: 151650406
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023; 01/26/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/03/2024; 01/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female