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

Catalog Number	150610009
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Edema (1820); Muscular Rigidity (1968); Pain (1994); Joint Disorder (2373); No Code Available (3191)
Date of Event	02/14/2017
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 17 june 2019 and were reviewed 20 september 2019 for mdr reportability.On (b)(6) 2015, the patient underwent total right knee arthroplasty due to osteoarthritis, and pain, and decreased activity.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 4.On (b)(6) 2017, the patient underwent a right knee revision due to loosening of the tibial component, and pain.The surgeon indicated the tibial tray was explanted and had no identifiable cement on the tray.He reported no loosening of the femoral component, and it was not revised.The surgeon noted the patellar component was retained, not revised.The patient was implanted with attune knee system and depuy cement x 2, and there were no complications reported with the procedure.Doi: (b)(6) 2015.Dor: (b)(6) 2017, (rt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).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.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
Update: medical records received ad 16 oct 2019 were reviewed on 07 nov 2019 for mdr reportability.Office visit notes (b)(6) 2015 indicate the patient is experiencing some angioedema of the face and lips, he took some benadryl and was noted to be improving.There is no indication that the depuy implants would have caused or contributed to this reaction.Office visit notes (b)(6) 2016 indicate the patient is experiencing clicking in his knee.Office visit notes (b)(6) 2016 indicate the patient is experiencing recurrent swelling, stiffness, pain and occasional instability.X-rays from this same visit interpret the following: loosening of the tibial component.Femoral component is intact.Office visit notes (b)(6) 2016 indicate the patient is also experiencing, in addition to what has been previously documented, mild patella-femoral crepitus and effusion noted.Office visit notes (b)(6) 2017 indicate the patient is status post revision and doing very well.Aspiration of effusion was performed, no indication of origin or outcome of effusion fluid.Following visit (b)(6) 2017 indicates no further concerns and it is indicated the knee is healing and functioning well.Office visit notes (b)(6) 2017 indicate the patient is status post revision and is experiencing intermittent stiffness, swelling and slight pain.Office visit notes (b)(6) 2019 indicate the patient is experiencing pain and swelling.Imagining was indicated to suggest patellar tendinitis and apparent hardware loosening of the tibial baseplate.There is no indication a secondary revision has occurred at this time within the medical records provided.
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.Added: h6 (no code available (3191) is used to capture the medical device removal) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP 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: 9191999
• Report Number: 1818910-2019-109939
• Device Sequence Number: 2599438
• Product Code: NJL
• UDI-Device Identifier: 10603295042631
• UDI-Public: 10603295042631
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 150610009
• Device Lot Number: 8048714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 11/18/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/12/2019; 11/18/2019
• 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 RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR