MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/20/2020
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
Medical records received ad (b)(6) 2021.Primary operative notes (b)(6) 2017 indicate the patient received a right total knee replacement due to end stage osteoarthritis with varus deformity.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.On an unk date the tibial insert was revised along with an irrigation and debridement due to infection and patient was placed on long term iv antibiotics.(product info for new insert not provided).Revision operative notes (b)(6) 2020 indicate the patient received a right total knee revision due to pain, swelling and chronic periprosthetic joint infection.Upon entering the joint, hypertrophic synovium and scar tissue was encountered and removed.The tibial, femoral and patella components were grossly loose at the cement to bone interface.All implants removed and antibiotic spacer placed.The surgery was completed without indication of complication by the surgeon.Doi: unknown (tibial insert), doi: (b)(6) 2017 (femoral, tibial base, patella and cement), dor: (b)(6) 2020 right knee.
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 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 FB TIB BASE SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11771183
• Report Number: 1818910-2021-09493
• Device Sequence Number: 3527232
• Product Code: NJL
• UDI-Device Identifier: 10603295042433
• UDI-Public: 10603295042433
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2021

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 Model Number: 1506-00-009
• Device Catalogue Number: 150600009
• Device Lot Number: 8413382
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 10/20/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/17/2021; 10/25/2021
• 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 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNKNOWN KNEE TIBIAL INSERT; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR