MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-109
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	04/30/2019
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
Patient received primary attune tkas to treat end-stage degenerative joint disease.The patella was resurfaced and competitor cement x 2 was utilized.The procedure was completed without complications.Patient received a left knee revision to treat pain secondary to aseptic loosening.Upon entering the joint, femoral osteolysis was identified.The femoral component was loosened at an unknown interface and revised.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.The loosened patella ¿just fell off¿ and was revised.The loosened interface of the patellar button was not provided.The patient was revised with a competitor revision knee.The procedure was completed without complications.Doi: (b)(6) 2015; dor: (b)(6) 2019; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11673289
• Report Number: 1818910-2021-08039
• Device Sequence Number: 11512984
• Product Code: JWH
• UDI-Device Identifier: 10603295041665
• UDI-Public: 10603295041665
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 1504-10-109
• Device Catalogue Number: 150410109
• Device Lot Number: 8036549
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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 MEDIAL ANAT PAT 41MM; ATTUNE PS FEM LT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR