MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-003
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient initiated complaint: it was reported by our patient that.She found my name/number on fda¿s recall site.She wanted to know if her attune knees implanted in germany were recalled.Attune knees germany original surgery (b)(6) 2014 bilateral revision surgery in texas left side in 2019 approximately (b)(6) (was not successful) revision on left (b)(6) 2020.Revision surgery in right in (b)(6) of 2021.Patient indicated she underwent bilateral tkas with attune implants on (b)(6) 2014 in germany.She underwent a revision of her left knee in 2019 for instability and tibial tray loosening (unknown interface or cement mfg involved).All implants were removed and its unknown what implants (manufacturer) were placed as revision.She underwent a revision of her right knee in (b)(6) of 2021 for instability and tibial tray loosening (unknown interface for cement mfg involved).All implants were removed and its unknown what implants (manufacturer) were placed as revision.The patient is seeking recall information.Patient was informed the part/lot information of the implants placed in 2014 is needed.Patient indicated she has this information and provide us with this information.Patient was provided her pc number for future reference and informed once part/lot information is received, we will assist with determining if her specific implants have been involved within any field actions/recalls.Patient indicated she continued to have instability problems post revision in 2019 of her left knee and had an intra-op fracture while implanting the new femoral component, but the implant mfg are unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).The initial reporter has been removed for confidentiality/privacy.The initial reporter is the 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.
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.

• Brand Name: ATTUNE FB TIB BASE SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16551665
• Report Number: 1818910-2023-05957
• Device Sequence Number: 5089014
• Product Code: JWH
• UDI-Device Identifier: 10603295042372
• UDI-Public: 10603295042372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1506-00-003
• Device Catalogue Number: 150600003
• Device Lot Number: 7913288
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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 FB INSRT SZ 3 5MM; ATTUNE CR FEM RT SZ 3 CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female