MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 10 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150610010
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	07/17/2018
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 received 17 june 2019 and were reviewed 07 october 2019 for mdr reportability.On (b)(6) 2017, the patient underwent total left knee arthroplasty due to osteoarthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and depuy bone cement x 2.On (b)(6) 2018, the patient underwent a left knee revision due to loosening, swelling, and pain.The surgeon indicated the removal of scar and adhesive tissue around the patella and lateral capsule.He reported the tibial baseplate was loose.He reported the femoral component to be tight without any motion, though was revised.The surgeon did not comment on the patella, though it was revised.The patient was implanted with depuy knee system and unknown cement.There were no complications reported with the procedure.Doi: (b)(6) 2017.Dor: (b)(6) 2018, (lt 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).Investigation summary : the device associated with this report was not 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 : 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.

• Brand Name: ATTUNE RP TIB BASE SZ 10 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9256845
• Report Number: 1818910-2019-113116
• Device Sequence Number: 19773807
• Product Code: NJL
• UDI-Device Identifier: 10603295042648
• UDI-Public: 10603295042648
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Catalogue Number: 150610010
• Device Lot Number: 8451738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR