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

Model Number 1504-10-104

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient had a left total knee arthroplasty to address osteoarthritis.Depuy component, including depuy patella, and depuy cement x2 were used during this procedure.On (b)(6) 2020, the patient had a left total knee revision to address loose tibial component.The surgeon reported that the femoral component was in slight valgus, which needed to be corrected and it was revised.The tibial component was noted to be grossly loose.Loosening was noted to be at the cement/implant interface.The insert was revised with no allegation of deficiency.The patella was not revised.Doi: (b)(6) 2014.Dor: (b)(6) 2020.(left knee).

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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
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> 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.********************************************** in order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot
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> 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 FEM LT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12825014
• MDR Text Key: 280875018
• Report Number: 1818910-2021-25281
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041610
• UDI-Public: 10603295041610
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1504-10-104
• Device Catalogue Number: 150410104
• Device Lot Number: 429745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• 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 FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 4 6MM; ATTUNE PS FEM LT SZ 4 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female