MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); No Code Available (3191); Joint Laxity (4526)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Patient was revised to address pain and instability.All components were well fixed.Surgeon removed femur tibia and insert and replaced with an attune revision knee with sleeves on both sides.Doi: (b)(6) 2016; dor: (b)(6) 2019; right side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: a2 (dob), d4 (expiration date), h6 (clinical and impact codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3: initial reporter occupation: lawyer.
Event or Problem Description
On (b)(6) 2016, the patient received a right attune total knee to treat degenerative joint disease.The patella was resurfaced and depuy cement was utilized.The surgeon noted the removal of a screw from the right knee from an unknown manufacturer implanted during a previous operation for an unknown reason.There were no indicated intra-operative complications.On (b)(6) 2019, the patient underwent a right knee revision to address pain, instability, and tibial tray loosening at the cement to implant interface.The surgeon noted the removal of excess scar tissue.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with depuy products and depuy cement x 1.There were no indicated intra-operative complications.
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.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 FB INSRT SZ 8 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8353469
• Report Number: 1818910-2019-85153
• Device Sequence Number: 1825987
• Product Code: JWH
• UDI-Device Identifier: 10603295050384
• UDI-Public: 10603295050384
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2019

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: 08/31/2017
• Device Model Number: 1516-40-810
• Device Catalogue Number: 151640810
• Device Lot Number: 278104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/25/2019; 06/04/2021; 07/09/2021
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/26/2019; 06/14/2021; 07/14/2021
• 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 8 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; SCREW (UNK MFR & PROD DETAILS); SMARTSET MV ENDURANCE 80G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 80