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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)
Date of Event	12/17/2018
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
Attune knee claim record received.Claim record alleges injuries, pain, anguish, disfigurement and physical impairment.Doi: (b)(6) 2016.Dor: (b)(6) 2018.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.
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.
Event or Problem Description
Medical records were reviewed: on (b)(6) 2016, the patient had bilateral total knee arthroplasty to address bilateral knee degenerative joint disease.Depuy components were used during this procedure, including depuy patella and depuy bone cement.(sticker page 7 of 15).On (b)(6) 2018, the patient had a left revision of tka to address failed left tka due to tibial component loosening.Indications for surgery included pain, and radiographic evidence showed progressive loosening.The femoral component and insert were removed with no allegation of deficiency doi: (b)(6) 2016.Dor: (b)(6) 2018 (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 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: a1 (date of birth), a2, b5, b7, d4 (expiration date).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, d6b, e1, g2.

• 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: 10104174
• Report Number: 1818910-2020-12890
• Device Sequence Number: 10971449
• Product Code: NJL
• UDI-Device Identifier: 10603295041665
• UDI-Public: 10603295041665
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2020

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: 02/29/2024
• Device Model Number: 1504-10-109
• Device Catalogue Number: 150410109
• Device Lot Number: 7856376
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 05/24/2021; 06/14/2021
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/03/2020; 06/03/2021; 06/20/2021
• 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 DOME PAT 41MM.; ATTUNE PS FEM LT SZ 9 CEM.; ATTUNE PS RP INSRT SZ9 5MM.; ATTUNE RP TIB BASE SZ 9 CEM.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; DEPUY CMW 2 20G; DEPUY CMW 2 20G; DEPUY CMW 2 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR