MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	06/17/2020
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
Primary operative notes (b)(6) 2017 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was not resurfaced, and competitor cement was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2020 indicate the patient received a left total knee revision due to aseptic loosening.Upon entering the joint, it is indicated that scarring was removed.The tibial component was loose, interface not provided.The femoral and insert components were also revised without indication of product deficiency.Depuy products were implanted, the patella was resurfaced and competitor cement was utilized.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2017.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.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.Corrected: b1: (product problem).B1: (product problem) should not have been checked since there was no reported product failure.

• Brand Name: ATTUNE PS FB INSRT SZ 4 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11154964
• Report Number: 1818910-2021-00886
• Device Sequence Number: 14422532
• Product Code: OIY
• UDI-Device Identifier: 10603295049814
• UDI-Public: 10603295049814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• 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): 01/05/2021

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: 02/28/2018
• Device Model Number: 1516-40-408
• Device Catalogue Number: 151640408
• Device Lot Number: 340686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/19/2021
• 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 2 CEM.; ATTUNE PS FEM LT SZ 4 NAR CEM.; STRYKER SIMPLEX BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR