MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 2 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number	150610003
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
The patient was operated on about a year ago and recently underwent a repeat operation due to suspicion of infection.When the knee opened towards the first stage, the knee did not appear to be contaminated at all, but the tibial surface was completely loose and was removed with the finger when there was no connection between the cement and the implant.As for the connection between the cement and the bone it seems that there is an excellent connection.As a result, it is likely that the cause of the patient's pain is not the infection but the weakening of the tibial surface.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.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 = > production code 150610003, work order 8619504 was manufactured on 13 september 2017.(b)(4) manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 2 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8687999
• Report Number: 1818910-2019-95727
• Device Sequence Number: 2349161
• Product Code: NJL
• UDI-Device Identifier: 10603295042563
• UDI-Public: 10603295042563
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150610003
• Device Lot Number: 8619504
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/14/2019; 08/05/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/22/2019; 08/06/2019
• 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