MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ4 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Event date(onset): (b)(6) 2022.Alert date: (b)(6) 2022.Country of event: ous procedure: tka using attune cementless: ps rp configuration date of procedure: (b)(6)2021 event description: right periprosthetic tka infection.Date of evaluation: (b)(6) 2022.Date of site awareness: (b)(6) 2022.Operative side: right.Did this adverse event occur intraoperatively?: no date of onset (or worsening, if applicable): (b)(6) 2022 is this a new or worsening event?: new event was this adverse event for the study knee?: yes was this adverse event classified as serious?: yes led to death: no resulted in a life-threatening illness or injury: no resulted in an impairment of a body structure or a body function: yes required in-patient hospitalization or prolongation of existing hospitalization: yes resulted in medical or surgical intervention to prevent permanent impairment to body structure or a body function: yes leads to fetal distress, fetal death or a congenital abnormality or birth defect: no was the subject readmitted to hospital?: yes the date of readmission: (b)(6) 2022 the date of discharge: (b)(6) 2022 was event expected/anticipated?: blank.Severity: severe.Relation to study device: not related.Relation to study procedure: not related action taken - none: no medical.Intervention/modification: no medical intervention/modification - specify: blank diagnostic intervention: no diagnostic intervention - specify: blank culture taken: no physical therapy: no.Observation: no.Manipulation under anesthesia: no.Manipulation under anesthesia date: blank pre-manipulation extension: blank pre-manipulation hyperextension: no pre-manipulation flexion: blank post-manipulation.Extension: blank post-manipulation hyperextension: no post-manipulation flexion: blank surgical intervention not for the study knee: no surgical intervention not for the study knee - specify: blank date of surgical intervention not for study knee: blank surgical intervention of the study knee: yes date of surgical intervention for study knee: (b)(6) 2022 i & d: yes.Arthroscopy: no.Isolated resurfacing of previously unsurfaced patella: no other procedure for study knee: yes other procedure for study knee - specify: polyethylene bearing linerexchange; insertion of prosthetic graft, stimulan beads with vancomycin and tobramycin.Components removed ¿ none: no.Femoral component removed: no.Tibial base removed: no.Tibial insert removed: yes patellar component (for previously resurfaced patella) removed: no other action taken: no other action taken - specify: blank adverse event outcome: recovering/resolving date of adverse event resolution/death: blank.Product details : log line: 1.Component type: femoral.Catalog number: 150411204.Product id/lot number: 8922637.Unique device identifier: (b)(4).Log line: 2.Component type: tibial.Catalog number: 150611004.Product id/lot number: 9614358.Unique device identifier: (b)(4).Log line: 3.Component type: insert.Catalog number: 151650405.Product id/lot number: 8718815.Unique device identifier: (b)(4).
Additional Manufacturer Narrative
Product complaint # :(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for 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.However, if the product is received at a later date, 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.

• Brand Name: ATTUNE PS RP INSRT SZ4 5MM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17163361
• Report Number: 1818910-2023-12531
• Device Sequence Number: 14907641
• Product Code: NJL
• UDI-Device Identifier: 10603295052289
• UDI-Public: 10603295052289
• Combination Product (Y/N): N
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 06/20/2023

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 Model Number: 1516-50-405
• Device Catalogue Number: 151650405
• Device Lot Number: 8718815
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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 FEM POR PS RT SZ 4; ATTUNE RP TIB BASE SZ 4 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown