MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Synovitis (2094)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
(b)(4) medical records ad 27 aug 2021 were reviewed.On (b)(6) 2016, the patient had a right total knee arthroplasty to address end-stage osteoarthritis, mainly involving patellofemoral joint.Depuy components, including depuy patella and depuy cement x2 were utilized during this procedure.On (b)(6) 2021, the patient had a revision right total arthroplasty to address aseptic loosening.The femoral, tibial tray, insert, and patella were revised.The patient was negative for infection.During the procedure the surgeon observed moderate amount of synovitis as well as scar tissue.The insert showed no significant wear but was revised.The tibial tray was loose at the implant to cement interface.The femoral component was not loose to palpitation, but fairly quickly loosened after using a saw blade and osteotomes.The preoperative bone scan results showed the patella as loose.The patella was removed for concerns of loosening, but no loosening was noted during the procedure.Competitor components were implanted, including competitor patella and competitor cement x3.Doi: (b)(6) 2016, dor: (b)(6) 2021 (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All photographs were reviewed and from the event information received, it was not possible to determine the relationship of the device to the reported event.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 CR FEM RT SZ 6 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12489537
• Report Number: 1818910-2021-20432
• Device Sequence Number: 4264897
• Product Code: JWH
• UDI-Device Identifier: 10603295041290
• UDI-Public: 10603295041290
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 1504-00-226
• Device Catalogue Number: 150400226
• Device Lot Number: C71748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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 CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 5MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 5MM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR