MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-225

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Voluntary report received as mw5111773.(b)(4) - sep 20 2022: patient called and spoke to clinician regarding her experience.She states that she had a primary of attune implants done in (b)(6) 2019.She has had pain, swelling, and "feeling like it is loose" since the primary was done.She has also been limited in the distance she can walk.A recent bone scan has shown lucencies "suggestive of loosening of the tibial tray." she states the doctor feels he can "pluck the tray right out because it is rocking back and forth." a revision has yet to be scheduled because the doctor wants to rule out any infection first.A biopsy is scheduled for (b)(6) 2022.The patient plans to call the patient correspondence voicemail or email if she is provided with any more updates.The device catalog number is unknown; therefore, udi is unavailable.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 Description

¿voluntary report received (mw5111773) depuy attune tibia plate failure.Fda safety report id# (b)(4)." doi: (b)(6) 2019, dor: unknown, affected side: unknown knee.

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.Removed infection in h6.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS FEM RT SZ 5 NAR CEM
• Type of Device: ATTUNE IMPLANT : 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15527436
• MDR Text Key: 301014917
• Report Number: 1818910-2022-19320
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041849
• UDI-Public: 10603295041849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-225
• Device Catalogue Number: 150410225
• Device Lot Number: J34U61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female