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

Model Number	1504-10-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
On (b)(6) 2015, the patient received an attune left total knee arthroplasty to address osteoarthritis.A cemented fixed bearing posterior stabilized knee was implanted, using 2 batches of depuy gentamycin bone cement.There were no reported complications.The patient's left knee was revised to address pain, swelling, and aseptic loosening of the femur and the tibial tray implants.The revising surgeon determined that the femur was grossly loose at the cement to bone interface, with the presence of a large cyst beneath the cement mantle.The tibial tray was also grossly loose, but in this case, it was loose at the implant to cement interface--there was no cement bonded to the backside of the tibial tray implant.The cement mantle was removed from the proximal bony tibia without significant bone loss.There was no evidence of effusion or infection, but there was extensive synovitis reported.The patient's primary patella was retained.During implantation of the revision femur construct, a non-displaced femoral fracture was identified, which was treated with two cerclage cables.The patient was placed on limited weight bearing precautions following the revision procedure to further address the bone fracture.Doi: (b)(6) 2016 dor: (b)(6) 2020 left knee.
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 PS FEM LT SZ 5 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11841168
• Report Number: 1818910-2021-10529
• Device Sequence Number: 19618559
• Product Code: JWH
• UDI-Device Identifier: 10603295041702
• UDI-Public: 10603295041702
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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 Expiration Date: 04/30/2024
• Device Model Number: 1504-10-125
• Device Catalogue Number: 150410125
• Device Lot Number: 7912167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 5 8MM; ATTUNE PS FEM LT SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 5 8MM; ATTUNE PS FEM LT SZ 5 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR