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

Model Number	1506-00-010
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scarring (2061); No Code Available (3191)
Date of Event	08/01/2017
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 23 jul 2018.Medical records were reviewed for mdr reportability.Patient underwent a left tka with depuy cement.The patella was not resurfaced.The patient then underwent a revision for pain and tightness.Intraoperative findings included chronic inflammation, tightness/scarring requiring a quadriceps snip for better visualization, loosening of the tibial tray at implant-cement interface, and a pitted insert.Doi: (b)(6) 2015; dor: (b)(6) 2017, (left).
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 = > 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.
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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE FB 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: 8718246
• Report Number: 1818910-2019-96400
• Device Sequence Number: 2212187
• Product Code: JWH
• UDI-Device Identifier: 10603295042440
• UDI-Public: 10603295042440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• 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): 06/03/2019

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: 12/31/2023
• Device Model Number: 1506-00-010
• Device Catalogue Number: 150600010
• Device Lot Number: 7830039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/29/2019; 09/25/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/29/2019; 09/28/2020
• 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: 51 YR