MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 CEM; JRN : KNEE FEMORAL

Model Number	1504-10-104
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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.
Event or Problem Description
¿mdr report received (mw5117924), on (b)(6) 2021, total knee revision with depuys attune knee implant.Poor recovery, range of motion, swelling, heat, pain were still present 6 months post op.On (b)(6) 2023, bone scan confirmed loosening of both the femoral and tibial components.Revision is scheduled for (b)(6) 2023.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot; a search of the depuy synthes quality management system was performed for the finished device lot number jm3147, and no non-conformances were identified.Furthermore this part and lot combination has not been recalled.
Additional Manufacturer Narrative
Product complaint # (b)(6).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.
Event or Problem Description
Clinical notes received.(b)(6) 2021 left total arthroplasty to address arthritis.Competitor cement along with depuy tibial tray, tibial insert, femoral component and patella were implanted.On (b)(6) /2022 the patient reports left knee pain and swelling, infection was noted.Medical records (b)(6) 2023 bone scan was noted show increased flow to the knee, which is suggestive of prosthetic loosening.There was no information provided that noted revision, invasive treatment, or permanent injury.

• Brand Name: ATTUNE PS FEM LT SZ 4 CEM
• Common Device Name: JRN : 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17144998
• Report Number: 1818910-2023-12390
• Device Sequence Number: 20179988
• Product Code: JWH
• UDI-Device Identifier: 10603295041610
• UDI-Public: 10603295041610
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2023

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: 1504-10-104
• Device Catalogue Number: 150410104
• Device Lot Number: JM3147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 07/13/2023; 07/17/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/14/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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 FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL ANAT PAT 32MM; UNK ATTUNE KNEE TIBIAL INSERT; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown