MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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 ad 30 mar 2020 were reviewed.On (b)(6) 2016, the patient underwent a computer-assisted right total knee arthroplasty to address osteoarthritis, pain and discomfort.Depuy components and depuy cement x2 were utilized during the primary surgery on (b)(6) 2019, the patient underwent a right knee revision to address pain, difficulty walking, stiffness ms pain with arthrofibrosis.The patella was found to be in good position and not revised.The femoral and insert components were removed with no allegation of deficiency.The tibial component had no cement adhered to the base plate.Competitor products were then implanted with unknown cement.No complications noted.Doi: (b)(6) 2016.Dor: (b)(6) 2019; (right knee).
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 7 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9979029
• Report Number: 1818910-2020-11008
• Device Sequence Number: 2437263
• Product Code: NJL
• UDI-Device Identifier: 10603295047995
• UDI-Public: 10603295047995
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 03/31/2018
• Device Model Number: 1516-30-706
• Device Catalogue Number: 151630706
• Device Lot Number: 3594799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR