MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; KNEE TIBIAL TRAY

Catalog Number	150670006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Cyst(s) (1800); Erythema (1840); Fall (1848); Unspecified Infection (1930); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Study no: dots.Clinical adverse event received for chronic infection, infection - deep.Device related: remote possibility.Procedure related: possibly.Date of event: 17/jul/2024.Date of implant: information not provided.Date of revision: information not provided.Device location: right.Treatment/impact: information not provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 performed.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.H11 additional narrative: added: b5, d4 (expiration date), h4, h6 (health effect - clinical code) corrected: d4 (primary udi number), h6 (health effect - impact code).
Event or Problem Description
Medical records received: on (b)(6)2024 medical records note the patient is one year post revision right knee.A few weeks after that surgery the patient fell and dehisced her wound.An emergency i&d was performed.Recently the patient had noticed some increased swelling.Physical examination notes moderate effusion with a an area of redness along the medial proximal tibia.Chronic infection noted, as an aspiration was performed.On (b)(6)2024 aspiration results from knee show a gram-positive cocci infection.The patient is on oral antibiotics.
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.H11 additional narrative: added: b5, h6 health effect - clinical code.Corrected: h6 health effect - impact code.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
Medical records received.On (b)(6) 2024, patient's right knee was revised to address chronic deep infection, secondary to a fall in (b)(6) 2023, that resulted in wound dehiscence (treated at that time with surgical irrigation & debridement and iv antibiotics--see (b)(4)), and then subsequently led to the patient's current pain, swelling, and limited range of motion at the time of this revision.On the day of surgery, patient presented with a large boil (infected cyst) and poor skin integrity at the previous surgical, site.Surgeon performed an extensive synovectomy to remove infected soft tissue.All total knee implants were explanted (they were well fixed), and an antibiotic impregnated spacer construct was implanted to treat the infection.There were no complications--patient tolerated the surgery well.

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19863262
• Report Number: 1818910-2024-16344
• Device Sequence Number: 8151016
• Product Code: JWH
• UDI-Device Identifier: 10603295492085
• UDI-Public: (01)10603295492085(17)321031(10)D22110977
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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: 150670006
• Device Lot Number: D22110977
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 08/13/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/08/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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 6 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CR RT MS INS SZ 6 8; DEPUY CMW 1 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 124 KG